Actively Recruiting
A Phase IIIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors
Led by Jacobio Pharmaceuticals Co., Ltd. · Updated on 2026-01-09
152
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating JAB-8263, a small-molecule inhibitor targeting BET proteins, in adult patients with advanced malignant solid and hematologic tumors in this Phase 12a open-label study. The study aims to find the highest safe dose, assess dose-limiting toxicities, evaluate safety and tolerability, and gather early evidence of antitumor activity in patients whose tumors have progressed despite standard treatments or lack standard options. The study has two parts dose escalation and dose expansion, each enrolling about 30 subjects. Participants receive JAB-8263 orally every two days in 28-day cycles, with dose adjustments to determine the recommended Phase 2 dose. The study monitors how the drug behaves in the body and its preliminary effects on tumors. Participants will undergo evaluations over approximately 18 months, including safety assessments, pharmacokinetic measurements, and tumor response evaluations using standardized criteria. Researchers will record adverse events, response rates, and survival outcomes while monitoring dose-related toxicities. The study does not use randomization or masking, and participants are closely followed to assess treatment effects and safety.
CONDITIONS
Brief Title
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- ECOG Performance Status score of 0 or 1
- Histologically or cytologically confirmed advanced solid tumors progressed despite standard therapies, intolerant to standard therapies, or without standard therapies
- Recurrent or refractory acute myeloid leukemia according to WHO 2016
- Life expectancy of at least 3 months
- At least one measurable lesion by RECIST v1.1 for solid tumor patients
- Sufficient baseline organ function
You will not qualify if you...
- History of cancer different from the cancer under study within the past 3 years
- Known serious allergy to the investigational drug or its components
- Active brain or spinal metastases
- History of pericarditis or Grade 2 or higher pericardial effusion
- History of interstitial lung disease
- Grade 2 or higher active infections within 2 weeks
- Known HIV infection
- Positive for hepatitis B virus
- Positive for hepatitis C virus or undetectable HCV-RNA viral levels
- Severe or uncontrolled medical conditions
- History of myocardial infarction, unstable angina, coronary artery bypass, or stroke
- Impaired cardiac function or significant cardiac diseases
- QTcF greater than 470 msec at screening
- History of significant thromboembolic events or bleeding disorders
- Unresolved toxicity greater than Grade 1
- History of malignant biliary obstruction
- Pregnant or breastfeeding
Research Team
J
Jacobio Pharmaceuticals
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