Actively Recruiting
A Phase I/IIa, 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 1/2a 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 months
Participants receive the study drug JAB-8263 orally every other day in 28-day cycles to assess safety, tolerability, and preliminary antitumor activity.
Visits every 2 to 4 weeks during treatment cycles
Trial Site Locations
Total: 1 location
1
Tianjin
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
Jacobio Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here