Back to resultsA First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
Primary Purpose
Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JAB-3312
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)
Eligibility Criteria
Inclusion Criteria:
- Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
- Subjects with life expectancy ≥3 months.
- Patients must have at least one measurable lesion as defined by RECIST v1.1.
- Patients who have sufficient baseline organ function.
Exclusion Criteria:
- Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
- Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
- History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
- 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- History or evidence of active infections (Grade ≥2).
- History or evidence of significant inflammatory or vascular eye disorder.
- History of an allogeneic bone marrow or solid organ transplant.
- Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
- History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
- History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
- Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.
Sites / Locations
- HealthONE Clinic Services Oncology-HematologyRecruiting
- Tennessee Oncology, PLLCRecruiting
- The University of Texas M. D. Anderson Cancer CenterRecruiting
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JAB-3312
Arm Description
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
Outcomes
Primary Outcome Measures
Number of participants with dose limiting toxicities
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3312.
Find Recommended Phase 2 Dose (RP2D) of JAB-3312
Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
Secondary Outcome Measures
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments
Area under the curve
Area under the plasma concentration time curve of JAB-3312
Cmax
Highest observed plasma concentration of JAB-3312
Tmax
Time of highest observed plasma concentration of JAB-3312
T1/2
Half life of JAB-3312
Objective response rate ( ORR )
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Duration of response ( DOR )
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Full Information
NCT ID
NCT04045496
First Posted
August 2, 2019
Last Updated
March 13, 2022
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04045496
Brief Title
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
Official Title
A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacobio Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Breast Cancer, Other Solid Tumors
Keywords
Src homology phosphatase 2 (SHP2), PTPN11, Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase, epidermal growth factor receptor (EGFR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JAB-3312
Arm Type
Experimental
Arm Description
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
Intervention Type
Drug
Intervention Name(s)
JAB-3312
Intervention Description
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicities
Description
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3312.
Time Frame
Approximately 2 years
Title
Find Recommended Phase 2 Dose (RP2D) of JAB-3312
Description
Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
Time Frame
Approximately 2 years
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments
Time Frame
Approximately 2 years
Title
Area under the curve
Description
Area under the plasma concentration time curve of JAB-3312
Time Frame
Approximately 2 years
Title
Cmax
Description
Highest observed plasma concentration of JAB-3312
Time Frame
Approximately 2 years
Title
Tmax
Description
Time of highest observed plasma concentration of JAB-3312
Time Frame
Approximately 2 years
Title
T1/2
Description
Half life of JAB-3312
Time Frame
Approximately 2 years
Title
Objective response rate ( ORR )
Description
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Time Frame
Approximately 2 years
Title
Duration of response ( DOR )
Description
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Time Frame
Approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
Subjects with life expectancy ≥3 months.
Patients must have at least one measurable lesion as defined by RECIST v1.1.
Patients who have sufficient baseline organ function.
Exclusion Criteria:
Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
History or evidence of active infections (Grade ≥2).
History or evidence of significant inflammatory or vascular eye disorder.
History of an allogeneic bone marrow or solid organ transplant.
Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobio Pharmaceuticals
Phone
86 10 56315466
Email
clinicaltrials@jacobiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobio Pharmaceuticals
Organizational Affiliation
Jacobio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
HealthONE Clinic Services Oncology-Hematology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
We'll reach out to this number within 24 hrs