Status:
RECRUITING
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Lead Sponsor:
Jacobio Pharmaceuticals Co., Ltd.
Conditions:
NSCLC
SCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. ...
Detailed Description
JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins. The objectives of this study are: To determine the maximum-tol...
Eligibility Criteria
Inclusion
- Subjects must meet all the following criteria in order to be included in the research study:
- 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(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.
- Subjects with recurrent/refractory AML according to WHO 2016
- Subjects with life expectancy ≥3 months.
- Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
- Patients who have sufficient baseline organ function.
Exclusion
- History (≤3 years) of cancer that is histologically distinct from the cancer under study.
- Known serious allergy to investigational drug or excipients
- Active brain or spinal metastases
- History of pericarditis or Grade ≥2 pericardial effusion
- History of interstitial lung disease.
- History of Grade ≥2 active infections within 2 weeks
- Known human immunodeficiency virus (HIV) infection
- Seropositive for hepatitis B virus (HBV)
- Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
- Any severe and/or uncontrolled medical conditions
- History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
- Impaired cardiac function or clinically significant cardiac diseases
- QTcF \>470 msec at screening
- History of medically significant thromboembolic events or bleeding diathesis
- Unresolved Grade \>1 toxicity
- History of malignant biliary obstruction
- Pregnant or breast-feeding
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04686682
Start Date
May 7 2021
End Date
July 1 2028
Last Update
January 9 2026
Active Locations (1)
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1
Tianjin
Tianjin, Tianjin Municipality, China, 300020