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First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

Primary Purpose

Advanced Solid Tumors Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-CLS-579
PD-1 inhibitor
VEGFR TKI
Sponsored by
Calico Life Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors Cancer focused on measuring Cancer, Tumor, ABBV-CLS-579, PD-1, VEGFR TKI, ccRCC, NSCLC, MSI-H, HNSCC

Eligibility Criteria

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

Inclusion Criteria:

  • Must weigh at least 35 kilograms (kg).
  • For Monotherapy and Combination Dose Escalation:

    • Histologically or cytologically proven metastatic or locally advanced tumors (with measurable disease defined by Response Evaluation Criteria In Solid Tumors [RECIST] v1.1), for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered.
  • For Combination Dose Expansion:

    • For the following tumor types, the subject must have received at least 1 prior line containing PD-1/PD-L1 target therapy.

Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease characteristics:

  • NSCLC

    • Relapsed: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved Agilent PD-L1 IHC 22C3 pharmDx kit
    • Refractory: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved Agilent PD-L1 IHC 22C3 pharmDx kit
  • ccRCC

    • Relapsed or Refractory: Advanced disease (locally advanced or metastatic)
  • MSI-H tumors

    • Refractory: Locally advanced or metastatic MSI-H tumors whose tumors are determined to have a MSI-H status by PCR or NGS tests, or dMMR by IHC tests.
  • HNSCC

    • Relapsed or Refractory: Tumors express PD-L1 (CPS ≥ 1] as determined by the FDA approved PD-L1 Agilent IHC 22C3 pharmDx kit
  • For Combination Dose Expansion:

    • Locally advanced or metastatic, advanced ccRCC who have relapsed after at least 1 prior VEGFR TKI therapy
  • Received at least 1 prior line containing PD 1/PD L1 targeted therapy with a best response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6 months)
  • Received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had disease progression (in the absence of best response of CR/PR/stable disease by RECIST v1.1) with PD 1/PD L1 targeted therapy
  • An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy of ≥ 12 weeks.
  • Laboratory values meeting protocol criteria.
  • If the subject is on anticoagulant therapy, INR must be within therapeutic goal.
  • QT interval corrected for heart rate < 450 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.

Exclusion Criteria:

  • Untreated brain or meningeal metastases (participants with history of metastases are eligible provide they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy).
  • Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
  • History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion, cardiac arrythmia or peripheral artery disease.
  • Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.
  • History of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug.
  • History of uncontrolled, clinically significant endocrinopathy.
  • Known gastrointestinal disorders making absorption of oral medications problematic. Inability to swallow capsules.
  • If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell death protein-ligand 1(aPD-L1) targeting or other immunostimulatory agents in the past: excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.
  • Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions)
  • History of solid organ transplant or allogeneic stem cell transplant.
  • History of interstitial lung disease or pneumonitis.
  • Major surgery ≤ 28 days prior to first dose of study drug.
  • Poorly controlled hypertension
  • History of hemorrhage, including hemoptysis, hematemesis, or melena
  • History of other malignancy, with the following exceptions:

    • No known active disease present for within 3 years before first dose of study treatment and felt to be at low recurrence by investigator
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    • Adequately treated carcinoma in situ without evidence of disease
  • Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.

Sites / Locations

  • Highlands Oncology Group SpringdaleRecruiting
  • Yale UniversityRecruiting
  • Fort Wayne Medical Oncology and HematologyRecruiting
  • Carolina BioOncology InstituteRecruiting
  • UPMC Hillman Cancer CenterRecruiting
  • Hopital Saint-AndreRecruiting
  • Institut Gustave RoussyRecruiting
  • The Chaim Sheba Medical CenterRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Wakayama Medical University HospitalRecruiting
  • National Cancer Center HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Monotherapy Dose Escalation

Combination Dose Escalation with PD-1

Backfill Cohorts with Monotherapy

Backfill Cohorts in Combination with PD-1

Combination Expansion with PD-1

Combination Expansion with VEGFR TKI

Arm Description

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors

ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors

ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC)

ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579
Maximum plasma/serum concentration of ABBV-CLS-579
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4
Maximum plasma/serum concentration of Metabolite M4
Maximum Observed Plasma/Serum Concentration (Cmax) Of PD-1 Inhibitor
Maximum plasma/serum concentration of PD-1 inhibitor
Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFR TKI
Maximum plasma/serum concentration of VEGFR TKI
Time To Cmax (Tmax) Of ABBV-CLS-579
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of Metabolite M4
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of PD-1 Inhibitor
The amount of time taken to reach Cmax
Time To Cmax (Tmax) Of VEGFR TKI
The amount of time taken to reach Cmax
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Rate Constant (β) Of VEGFR TKI
Terminal phase elimination rate constant (β or Beta)
Terminal Phase Elimination Half-Life (t1/2) Of ABBV-CLS-579
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Half-Life (t1/2) Of Metabolite M4
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Half-Life (t1/2) Of PD-1 Inhibitor
Terminal phase elimination half-life (t1/2)
Terminal Phase Elimination Half-Life (t1/2) Of VEGFR TKI
Terminal phase elimination half-life (t1/2)
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579
The Expansion Dose and/or MTD of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor
The Expansion Dose and/or MTD of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Base On Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ABBV-CLS-579 in locally or metastatic HNSCC, NSCLC, MSI-H tumors, and advanced ccRCC
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Objective Response Rate (ORR) on RECIST v1.1, of ABBV-CLS-579 administered in combination with VEGFR TKI in advanced ccRCC
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment

Secondary Outcome Measures

Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Objective Response Rate (ORR) Of ABBV-CLS-579 Monotherapy Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Change from Baseline QTc
QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline

Full Information

First Posted
June 3, 2020
Last Updated
July 19, 2023
Sponsor
Calico Life Sciences LLC
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04417465
Brief Title
First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors
Official Title
A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calico Life Sciences LLC
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI. ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors. The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation, and Part 3 Combination Dose Expansion. Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in combination with a PD-1 target agent or with a VEGFR TKI in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists or has failed will be enrolled. Participants will receive study treatment until disease progresses or discontinued. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors Cancer
Keywords
Cancer, Tumor, ABBV-CLS-579, PD-1, VEGFR TKI, ccRCC, NSCLC, MSI-H, HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy Dose Escalation
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors
Arm Title
Combination Dose Escalation with PD-1
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
Arm Title
Backfill Cohorts with Monotherapy
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered as a monotherapy in subjects with solid tumors
Arm Title
Backfill Cohorts in Combination with PD-1
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered in combination with Programmed Cell Death-1 Inhibitor in subjects with solid tumors
Arm Title
Combination Expansion with PD-1
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), microsatellite instability-high (MSI-H) tumors, and advanced clear cell renal cell carcinoma (ccRCC)
Arm Title
Combination Expansion with VEGFR TKI
Arm Type
Experimental
Arm Description
ABBV-CLS-579 will be administered at the determined recommended dose in combination with Vascular Endothelial Growth (VEGFR) Factor Receptor Tyrosine Kinase Inhibitor (TKI) in subjects with advanced ccRCC.
Intervention Type
Drug
Intervention Name(s)
ABBV-CLS-579
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
VEGFR TKI
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Maximum Observed Plasma/Serum Concentration (Cmax) Of ABBV-CLS-579
Description
Maximum plasma/serum concentration of ABBV-CLS-579
Time Frame
Baseline Up to Approximately Day 44
Title
Maximum Observed Plasma/Serum Concentration (Cmax) Of Metabolite M4
Description
Maximum plasma/serum concentration of Metabolite M4
Time Frame
Baseline Up to Approximately Day 44
Title
Maximum Observed Plasma/Serum Concentration (Cmax) Of PD-1 Inhibitor
Description
Maximum plasma/serum concentration of PD-1 inhibitor
Time Frame
Baseline Up to Approximately Day 64
Title
Maximum Observed Plasma/Serum Concentration (Cmax) Of VEGFR TKI
Description
Maximum plasma/serum concentration of VEGFR TKI
Time Frame
Baseline Up to Approximately Day 64
Title
Time To Cmax (Tmax) Of ABBV-CLS-579
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 44
Title
Time To Cmax (Tmax) Of Metabolite M4
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 44
Title
Time To Cmax (Tmax) Of PD-1 Inhibitor
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 64
Title
Time To Cmax (Tmax) Of VEGFR TKI
Description
The amount of time taken to reach Cmax
Time Frame
Baseline Up to Approximately Day 64
Title
Terminal Phase Elimination Rate Constant (β) Of ABBV-CLS-579
Description
Terminal phase elimination rate constant (β or Beta)
Time Frame
Baseline Up to Approximately Day 44
Title
Terminal Phase Elimination Rate Constant (β) Of Metabolite M4
Description
Terminal phase elimination rate constant (β or Beta)
Time Frame
Baseline Up to Approximately Day 44
Title
Terminal Phase Elimination Rate Constant (β) Of PD-1 Inhibitor
Description
Terminal phase elimination rate constant (β or Beta)
Time Frame
Baseline Up to Approximately Day 64
Title
Terminal Phase Elimination Rate Constant (β) Of VEGFR TKI
Description
Terminal phase elimination rate constant (β or Beta)
Time Frame
Baseline Up to Approximately Day 64
Title
Terminal Phase Elimination Half-Life (t1/2) Of ABBV-CLS-579
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 44
Title
Terminal Phase Elimination Half-Life (t1/2) Of Metabolite M4
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 44
Title
Terminal Phase Elimination Half-Life (t1/2) Of PD-1 Inhibitor
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 64
Title
Terminal Phase Elimination Half-Life (t1/2) Of VEGFR TKI
Description
Terminal phase elimination half-life (t1/2)
Time Frame
Baseline Up to Approximately Day 64
Title
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of ABBV-CLS-579
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 44
Title
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of Metabolite M4
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 44
Title
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of PD-1 Inhibitor
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 64
Title
Area Under The Plasma Or Serum Concentration-Time Curve (AUC) Of VEGFR TKI
Description
AUC is the area under the serum concentration versus time curve of the last measurable concentration prior to next dose
Time Frame
Baseline Up to Approximately Day 64
Title
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579
Description
The Expansion Dose and/or MTD of ABBV-CLS-579 will be determined during the monotherapy dose escalation phase of the study
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Recommended Expansion Dose and/or Maximum Tolerated Dose of ABBV-CLS-579 and a PD-1 Inhibitor
Description
The Expansion Dose and/or MTD of ABBV-CLS-579 and PD-1 inhibitor will be determined during the combination therapy dose escalation phase of the study
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Base On Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ABBV-CLS-579 in locally or metastatic HNSCC, NSCLC, MSI-H tumors, and advanced ccRCC
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Objective Response Rate (ORR) on RECIST v1.1, of ABBV-CLS-579 administered in combination with VEGFR TKI in advanced ccRCC
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Objective Response Rate (ORR) Of ABBV-CLS-579 Monotherapy Based On Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Description
ORR is defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Best Overall Response (BOR) Of ABBV-CLS-579 Monotherapy Based On RECIST v1.1
Description
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Best Overall Response (BOR) Of ABBV-CLS-579 And PD-1 Targeting Agent Based On RECIST v1.1
Description
BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence
Time Frame
Baseline through Study Completion (approximately 3 years)
Title
Change from Baseline QTc
Description
QT prolongation is measured by the QT interval measurement corrected for heart rate (QTc) change from baseline
Time Frame
Baseline through Study Completion (approximately 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must weigh at least 35 kilograms (kg). For Monotherapy and Combination Dose Escalation: Histologically or cytologically proven metastatic or locally advanced tumors (with measurable disease defined by Response Evaluation Criteria In Solid Tumors [RECIST] v1.1), for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered. For Combination Dose Expansion: For the following tumor types, the subject must have received at least 1 prior line containing PD-1/PD-L1 target therapy. Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease characteristics: NSCLC Relapsed: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved Agilent PD-L1 IHC 22C3 pharmDx kit Refractory: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved Agilent PD-L1 IHC 22C3 pharmDx kit ccRCC Relapsed or Refractory: Advanced disease (locally advanced or metastatic) MSI-H tumors Refractory: Locally advanced or metastatic MSI-H tumors whose tumors are determined to have a MSI-H status by PCR or NGS tests, or dMMR by IHC tests. HNSCC Relapsed or Refractory: Tumors express PD-L1 (CPS ≥ 1] as determined by the FDA approved PD-L1 Agilent IHC 22C3 pharmDx kit For Combination Dose Expansion: Locally advanced or metastatic, advanced ccRCC who have relapsed after at least 1 prior VEGFR TKI therapy Received at least 1 prior line containing PD 1/PD L1 targeted therapy with a best response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than 6 months) Received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had disease progression (in the absence of best response of CR/PR/stable disease by RECIST v1.1) with PD 1/PD L1 targeted therapy An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Life expectancy of ≥ 12 weeks. Laboratory values meeting protocol criteria. If the subject is on anticoagulant therapy, INR must be within therapeutic goal. QT interval corrected for heart rate < 450 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings. Exclusion Criteria: Untreated brain or meningeal metastases (participants with history of metastases are eligible provide they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy). Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia. History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion, cardiac arrythmia or peripheral artery disease. Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease. History of clinically significant medical and/or psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug. History of uncontrolled, clinically significant endocrinopathy. Known gastrointestinal disorders making absorption of oral medications problematic. Inability to swallow capsules. If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell death protein-ligand 1(aPD-L1) targeting or other immunostimulatory agents in the past: excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation. Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions) History of solid organ transplant or allogeneic stem cell transplant. History of interstitial lung disease or pneumonitis. Major surgery ≤ 28 days prior to first dose of study drug. Poorly controlled hypertension History of hemorrhage, including hemoptysis, hematemesis, or melena History of other malignancy, with the following exceptions: No known active disease present for within 3 years before first dose of study treatment and felt to be at low recurrence by investigator Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
847.283.8955
Email
abbvieclinicaltrials@abbvie.com
Facility Information:
Facility Name
Highlands Oncology Group Springdale
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Richmond
Phone
479-872-8130
First Name & Middle Initial & Last Name & Degree
Joseph Beck
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erina Sarker
Phone
475-301-4070
First Name & Middle Initial & Last Name & Degree
Patricia LoRusso
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandy Irmiter
Phone
206-436-0800
First Name & Middle Initial & Last Name & Degree
Sunil Babu
Facility Name
Carolina BioOncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Noldin
Phone
704-947-6599
First Name & Middle Initial & Last Name & Degree
John Powderly
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Behr
Phone
412-623-6028
First Name & Middle Initial & Last Name & Degree
Jason Luke
Facility Name
Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
05-56-79-47-08
First Name & Middle Initial & Last Name & Degree
Amaury Daste
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
01-42-11-46-72
First Name & Middle Initial & Last Name & Degree
Rastislav Bahleda
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
972-3-5304498
First Name & Middle Initial & Last Name & Degree
Talia Golan
Facility Name
National Cancer Center Hospital East
City
Kashiwa-Shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-04-7133-1111
First Name & Middle Initial & Last Name & Degree
Nobuaki Matsubara
Facility Name
Wakayama Medical University Hospital
City
Wakayama-Shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-073-447-2300
First Name & Middle Initial & Last Name & Degree
Toshio Shimizu
Facility Name
National Cancer Center Hospital
City
Chuo-ku, Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81-335422511
First Name & Middle Initial & Last Name & Degree
Noboru Yamamoto
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82-2-741-4221
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34 915504800
Ext
2805
First Name & Middle Initial & Last Name & Degree
Victor Moreno Garcia
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34 913-908-923
First Name & Middle Initial & Last Name & Degree
Jon Zugazagoitia Fraile
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34-917567825
First Name & Middle Initial & Last Name & Degree
Emiliano Calvo Aller
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
951-032-250
First Name & Middle Initial & Last Name & Degree
Javier Garcia Corbacho
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886-2-23123456
Ext
67680
First Name & Middle Initial & Last Name & Degree
Chia-Chi Lin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

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