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APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA)

Primary Purpose

Solid Tumors, Advanced Cancer, Renal Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APL-101 Oral Capsules
Sponsored by
Apollomics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring Advanced Solid Tumor, Relapsed Solid Tumor, Recurrent Solid Tumor, cMet exon 14 skipping, cMet fusion, GBM, HGF, EGFR positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
  • For Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy (Completed).
  • For Phase 2, seven cohorts will be enrolled:

Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve) pretreated subjects with no more than 3 lines of prior therapy, Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met inhibitor), Cohort C: basket of tumor types with c-Met high level amplification (except Primary CNS tumors), Cohort C-1: NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR) with no more than 3 lines of prior therapy (MET Naive), Cohort D: basket of tumor types except for primary CNS tumors harboring MET gene fusions (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer). Previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting). Met naive, Cohort E: Primary CNS tumors with MET alterations (single or co-occurred MET fusion including PTPRZ1-MET [ZM] fusion, MET Exon 14 skipping mutation, or MET amplification).Previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines), Met naive.

- Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is required (except in Cohort A-1 in the US and Cohort C-1).

In Phase 2, provision of either archival or a fresh tumor biopsy sample (if safe and feasible) either from the primary or a metastatic site is required for study entry for Cohorts A-1, A-2, C, C-1, and D.

  • Measurable disease according to relevant criteria (RECIST v1.1, RANO for CNS tumors, or other relevant criteria per tumor type).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and/or Karnofsky Performance Scale (KPS) score.
  • For all prior anticancer treatment, including radiotherapy, chemotherapy or targeted agents or hormonal therapy, a duration of more than 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment. Palliative radiotherapy to non-target lesions should be completed within 2 weeks prior to APL-101 administration.
  • No planned major surgery within 4 weeks of first dose of APL-101
  • Expected survival (life expectancy) ≥ 3 months from C1D1.

Major Exclusion Criteria:

  • Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known actionable mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
  • Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy, history of congenital prolonged QT syndrome, prolonged QT interval corrected by Fridericia formula (QTcF) at screening (> 450 msec based on the average of 3 measurements), or concurrent treatment with a medication that is a known risk for prolonging the QT interval.
  • Unable to swallow orally administered medication whole.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).

Symptomatic and/or neurologically unstable CNS metastases, or who require an increase in steroid dose to control CNS disease. Subjects who have been receiving a stable steroid dose for at least 2 weeks prior to C1D1 may be allowed.

- Women who are breastfeeding.

Sites / Locations

  • Loma Linda University Medical Center
  • University of Southern California / Norris Comprehensive Cancer Center
  • Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer InstituteRecruiting
  • Kaiser Permanente - CARecruiting
  • UCSF - Helen Diller Family Comprehensive Cancer Center
  • Providence Medical FoundationRecruiting
  • Providence St. Joseph HealthRecruiting
  • Kaiser Permanente - VallejoRecruiting
  • Christiana HospitalRecruiting
  • Florida Cancer Specialists - SouthRecruiting
  • Miami Cancer InstituteRecruiting
  • Florida Cancer Specialists - NorthRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Moffitt
  • Florida Cancer SpecialistsRecruiting
  • Maryland Oncology HematologyRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Dana Farber Cancer Institute
  • Mayo Clinic
  • HealthPartners Cancer Research CenterRecruiting
  • Washington University School of MedicineRecruiting
  • University of North CarolinaRecruiting
  • Wake Forest University Health SciencesRecruiting
  • The Ohio State University (OSU)Recruiting
  • Ohio Health Research InstituteRecruiting
  • Penn State Milton S. Hershey Medical CenterRecruiting
  • St. Francis Cancer CenterRecruiting
  • Sarah Cannon and HCA Research InstituteRecruiting
  • The Don & Sybil Harrington Cancer CenterRecruiting
  • West Virginia University Cancer InstituteRecruiting
  • University of WisconsinRecruiting
  • Flinders Medical CentreRecruiting
  • Border Medical OncologyRecruiting
  • Peninsula and Southeast OncologyRecruiting
  • St Vincents Hospital MelbourneRecruiting
  • Sir Charles Gairdner HospitalRecruiting
  • Calvary Central Districts Hospita
  • Lady Davis Institute for Medical Research Jewish General HospitalRecruiting
  • Cross Cancer InstituteRecruiting
  • McGill University Health Center - Research InstituteRecruiting
  • Princess Margaret HospitalRecruiting
  • Cancer Care ManitobaRecruiting
  • Tampere University HospitalRecruiting
  • CHRU de Brest - Hôpital MorvanRecruiting
  • CHRU de LilleRecruiting
  • Centre Leon BerardRecruiting
  • Centre d'Essais Precoces en Cancerologie de MarseilleRecruiting
  • Hopital Bichat - Claude Bernard - AP-HPRecruiting
  • CHU Rennes - Hopital PontchaillouRecruiting
  • Gustave RoussyRecruiting
  • Orszagos Koranyi Pulmonologiai IntezetRecruiting
  • Szent Borbala KorhazRecruiting
  • Torokbalinti TudogyogyintezetRecruiting
  • Azienda Ospedaliero-Universitaria delle MarcheRecruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaRecruiting
  • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. RodolicoRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • Istituto Europeo di OncologiaRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale BusoneraRecruiting
  • AOU Citta della Salute e della Scienza di Torino - Ospedale le MolinetteRecruiting
  • PanOncology Trials, LLCRecruiting
  • Arkhangelsk Clinical Oncological Dispensary
  • JSC Group of companies Medsi
  • Private Medical Institution Euromedservice
  • Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
  • Ogarev Mordovia State University
  • JSC Current Medical Technologies
  • Volgograd Regional Clinical Oncology Dispensary
  • National Cancer Centre SingaporeRecruiting
  • Oncocare Cancer CentreRecruiting
  • Tan Tock Seng HospitalRecruiting
  • Hospital Germans Trias i PujolRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Hospital del MarRecruiting
  • Institut Catala d'Oncologia - L'HospitaletRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Instituto Valenciano de OncologiaRecruiting
  • Taichung Veterans General HospitalRecruiting
  • Chi-Mei Hospital - Liouying BranchRecruiting
  • National Taiwan University HospitalRecruiting
  • Linkou Chang Gung Memorial Hospital (CGMHLK)Recruiting
  • Imperial College Healthcare NHS Trust
  • University College London HospitalRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • Royal Marsden Hospital - SurreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NSCLC Exon 14 Skip Treatment Naive

NSCLC Exon 14 Skip Previously Treated

NSCLC Exon 14 MET Inhibitor Experienced

Basket of tumor types MET amplification except for primary CNS tumors

NSCLC MET amplification and EGFR wild-type

EGFR positive NSCLC MET amplification as an acquired resistance

Basket of solid tumor with MET gene fusions except for primary CNS tumors

Primary CNS tumors with MET alterations

Basket of tumor types wild-type MET with over-expression of HGF and MET

Arm Description

Cohort A-1: APL-101 Oral Capsules

Cohort A-2: APL-101 Oral Capsules

Cohort B: APL-101 Oral Capsules

Cohort C: APL-101 Oral Capsules

Cohort C-1: APL-101 Oral Capsules

Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor

Cohort D: APL-101 Oral Capsules

Cohort E: APL-101 Oral Capsules

Cohort F: APL-101 Oral Capsules

Outcomes

Primary Outcome Measures

Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.

Secondary Outcome Measures

Median duration of response (DOR) per IRC.
DOR per RECIST v1.1 criteria, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
ORR per investigator assessment based on RECIST v1.1.
ORR per RECIST v1.1 or relevant evaluation criteria per tumor type.
Median DOR per investigator assessment.
DOR per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).
Benefit rate per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Median time to progression (TTP).
TTP per RECIST v1.1 or relevant evaluation criteria per tumor type.
Progression Free Survival (PFS) and overall survival (OS) at 6, 12, 18 and 24 months
PFS and OS per RECIST v1.1 or relevant evaluation criteria per tumor type.

Full Information

First Posted
June 1, 2017
Last Updated
October 19, 2023
Sponsor
Apollomics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03175224
Brief Title
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Acronym
SPARTA
Official Title
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apollomics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess: efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)
Detailed Description
Phase 1 (lead-in stage of this study) enrollment has been completed. In this Phase 2 study, efficacy, safety, and tolerability will be assessed in the following cohorts: Cohort A-1: NSCLC EXON 14 skip mutation, previously untreated, MET inhibitor naive (c-Met naïve, 1L) Cohort A-2: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor naive (c-Met naïve, 2/3L) Cohort B: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor experienced (c-Met experienced; progressed on prior c-Met inhibitor) Cohort C: basket of tumor types (e.g., NSCLC, upper gastrointestinal [GI], colorectal, hepatobiliary cancer) harboring MET amplification except for primary CNS tumors, previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve Cohort C-1: NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR), previously treated; or untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve Cohort C-2: EGFR positive NSCLC harboring MET amplification as an acquired resistance, documented response with first-line EGFR-Inhibitor (PR or CR per RECIST ≥ 12 weeks), radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy, MET inhibitor naïve Cohort D: basket of tumor types except for primary CNS tumors harboring MET gene fusions (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve Cohort E: primary CNS tumors with MET alterations (single or co-occurred MET fusion including PTPRZ1-MET [ZM] fusion, MET Exon 14 skipping mutation, or MET amplification), previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines), MET inhibitor naïve Cohort F: basket of tumor types harboring wild-type MET with over-expression of HGF and MET (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer or primary CNS tumors), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Advanced Cancer, Renal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, NSCLC, Lung Cancer, Brain Tumor, Glioblastoma Multiforme, EGFR Gene Mutation, MET Amplification, HGF, Thyroid Cancer, Pancreatic Cancer, Colon Cancer, MET Alteration, MET Fusion, Exon 14 Skipping
Keywords
Advanced Solid Tumor, Relapsed Solid Tumor, Recurrent Solid Tumor, cMet exon 14 skipping, cMet fusion, GBM, HGF, EGFR positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
497 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSCLC Exon 14 Skip Treatment Naive
Arm Type
Experimental
Arm Description
Cohort A-1: APL-101 Oral Capsules
Arm Title
NSCLC Exon 14 Skip Previously Treated
Arm Type
Experimental
Arm Description
Cohort A-2: APL-101 Oral Capsules
Arm Title
NSCLC Exon 14 MET Inhibitor Experienced
Arm Type
Experimental
Arm Description
Cohort B: APL-101 Oral Capsules
Arm Title
Basket of tumor types MET amplification except for primary CNS tumors
Arm Type
Experimental
Arm Description
Cohort C: APL-101 Oral Capsules
Arm Title
NSCLC MET amplification and EGFR wild-type
Arm Type
Experimental
Arm Description
Cohort C-1: APL-101 Oral Capsules
Arm Title
EGFR positive NSCLC MET amplification as an acquired resistance
Arm Type
Experimental
Arm Description
Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor
Arm Title
Basket of solid tumor with MET gene fusions except for primary CNS tumors
Arm Type
Experimental
Arm Description
Cohort D: APL-101 Oral Capsules
Arm Title
Primary CNS tumors with MET alterations
Arm Type
Experimental
Arm Description
Cohort E: APL-101 Oral Capsules
Arm Title
Basket of tumor types wild-type MET with over-expression of HGF and MET
Arm Type
Experimental
Arm Description
Cohort F: APL-101 Oral Capsules
Intervention Type
Drug
Intervention Name(s)
APL-101 Oral Capsules
Other Intervention Name(s)
PLB-1001, CBI-3103, Bozitinib, CBT-101, Vebreltinib
Intervention Description
Subjects will receive APL-101 capsules BID for oral administration.
Primary Outcome Measure Information:
Title
Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Description
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Time Frame
From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression
Secondary Outcome Measure Information:
Title
Median duration of response (DOR) per IRC.
Description
DOR per RECIST v1.1 criteria, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Time Frame
Approximately 2 years
Title
ORR per investigator assessment based on RECIST v1.1.
Description
ORR per RECIST v1.1 or relevant evaluation criteria per tumor type.
Time Frame
Approximately 2 years
Title
Median DOR per investigator assessment.
Description
DOR per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Time Frame
Approximately 2 years
Title
Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).
Description
Benefit rate per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Time Frame
Approximately 2 years
Title
Median time to progression (TTP).
Description
TTP per RECIST v1.1 or relevant evaluation criteria per tumor type.
Time Frame
Approximately 2 years
Title
Progression Free Survival (PFS) and overall survival (OS) at 6, 12, 18 and 24 months
Description
PFS and OS per RECIST v1.1 or relevant evaluation criteria per tumor type.
Time Frame
Approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: Men and women 18 years of age or older. 9 cohorts will be enrolled: Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); treatment-naive subjects in first line; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); pretreated subjects refractory to or intolerant of standard therapies with no more than three lines of prior therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort B / Exon 14 NSCLC MET inhibitor experienced: ENROLLMENT COMPLETED Cohort C / MET amplification basket tumor types excluding primary CNS tumors: Any solid tumor type regardless of histology excluding primary CNS tumors, with MET amplification; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort C1 / MET amplification and wild-type EGFR NSCLC: NSCLC regardless of histology, harboring MET amplification and wild-type EGFR; unresectable or metastatic disease, previously untreated or treated with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort C2 / EGFR positive NSCLC with acquired MET amplification (APL-101 Add-on Therapy): Unresectable or metastatic NSCLC regardless of histology, harboring EGFR activating mutations with acquired MET-Amplification as resistance mechanism to the EGFR-I; developed resistance to first-line EGFR-inhibitor therapy after an initial response (documented PR for at least 12 weeks); radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy; currently on an EGFR-inhibitor therapy and agrees to receive APL-101 as an add-on therapy during the study; no history of interstitial lung disease (ILD)/pneumonitis, Grade ≥3 liver toxicity or QT prolongation with EGFR-I therapy; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort D / MET fusion basket tumor types excluding primary CNS tumors: any solid tumor type regardless of histology excluding primary CNS tumors; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Cohort E / Primary CNS tumors with MET alterations: subjects with primary CNS tumors who meet inclusion criteria of MET dysregulations defined as single or co-occurred MET fusion including PTPRZ1-MET (ZM) fusion, MET Exon 14 skipping mutations, or MET amplification; refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations; neurological symptoms controlled on a stable/decreasing dose of steroids for at least 2 weeks before C1D1 Cohort F / Basket tumor types harboring wild-type MET with over-expression of HGF and MET: any solid tumor type regardless of histology harboring wild-type MET with overexpression of HGF and MET; Unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations Treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed. Presence of ≥1 measurable lesion (scan done ≤28 days of C1D1) to serve as target lesion according to relevant criteria ECOG performance status of 0-1. For subjects with primary CNS tumors, KPS score ≥70. Acceptable organ function For all prior anticancer treatment, a duration of 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment. Palliative radiotherapy to non-target lesions should be completed within 2 weeks prior to APL-101 administration. Adequate cardiac function Women of child-bearing potential must have a negative serum or Beta-hCG at screening or evidence of surgical sterility or evidence of post-menopausal status No planned major surgery within 4 weeks of first dose of APL-101 Expected survival (life expectancy) ≥ 3 months from C1D1 Provision of sample; e.g. archival or a fresh tumor biopsy sample (if safe and feasible) either from the primary or a metastatic site) or liquid biopsy sample (if tumor tissue is insufficient or lacking, and approved by the sponsor) is required for prospective central lab confirmation for study entry (subjects with previously confirmed molecular status by the Sponsor designated central lab or FDA approved NGS based MET testing may be exempted, subjected to Sponsor approval. Major Exclusion Criteria: Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen. Known actionable mutation/gene rearrangement of EGFR (except for NSCLC subjects in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF. Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination. Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk: benefit unfavorable for the participation of the trial. Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator's opinion, could compromise the subject's safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of APL-101. Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy, history of congenital prolonged QT syndrome, prolonged QT interval corrected by Fridericia formula (QTcF) at screening, or concurrent treatment with a medication that is a known risk for prolonging the QT interval. Chronic controlled atrial fibrillation is not excluded. Historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) with high viral loads not actively managed with antiviral therapy and human immunodeficiency virus (HIV) positive subjects who are not clinically stable or controlled on their medication (asymptomatic subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/μL and have not had an opportunistic infection within the past 12 months prior to first dose of APL-101 would be eligible for study entry. If history is unclear, relevant test(s) at Screening will be required to confirm eligibility. Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments. Unable to swallow orally administered medication whole. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption Women who are breastfeeding History of another malignancy within 3 years prior to C1D1. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years: Carcinoma of the skin without melanomatous features. Curatively treated cervical carcinoma in situ. Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment, prostate cancer which has been surgically or medically treated and not likely to recur within 3 years. Subjects who are unable or unwilling to discontinue excluded medications (drugs with known QTc risk and known strong cytochrome P450 [CYP]3A4 inducer and/or strong inhibitors) for at least 5 half-lives prior to first dose of study drug. Subjects may qualify if such medication(s) can be safely replaced with alternate medications with less risk of drug-drug interaction. Subjects with active COVID-19 infection. Symptomatic and/or neurologically unstable CNS metastases, or who require an increase in steroid dose to control CNS disease. Subjects who have been receiving a stable steroid dose for at least 2 weeks prior to C1D1 may be allowed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Huey
Phone
6502094055
Email
clinops@apollomicsinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marietta Franco
Organizational Affiliation
Apollomics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Southern California / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente - CA
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF - Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Providence Medical Foundation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence St. Joseph Health
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
HealthPartners Cancer Research Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University (OSU)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon and HCA Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
The Don & Sybil Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia University Cancer Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BSN
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Name
Border Medical Oncology
City
Albury
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peninsula and Southeast Oncology
City
Frankston
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincents Hospital Melbourne
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Central Districts Hospita
City
North Adelaide
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Lady Davis Institute for Medical Research Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Center - Research Institute
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Hospital
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cancer Care Manitoba
City
Winnipeg
Country
Canada
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU de Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Name
Centre d'Essais Precoces en Cancerologie de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat - Claude Bernard - AP-HP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Name
Orszagos Koranyi Pulmonologiai Intezet
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szent Borbala Korhaz
City
Tatabanya
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Torokbalinti Tudogyogyintezet
City
Torokbalint
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria delle Marche
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Name
PanOncology Trials, LLC
City
Rio Piedras
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Arkhangelsk Clinical Oncological Dispensary
City
Arkhangelsk
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
JSC Group of companies Medsi
City
Otradnoye
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Private Medical Institution Euromedservice
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Ogarev Mordovia State University
City
Saransk
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
JSC Current Medical Technologies
City
St. Petersburg
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Oncocare Cancer Centre
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia - L'Hospitalet
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi-Mei Hospital - Liouying Branch
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital (CGMHLK)
City
Taoyuan City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital - Surrey
City
Surrey Quays
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.apollomicsinc.com
Description
Apollomics, Inc. website

Learn more about this trial

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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