Actively Recruiting
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Led by Jacobio Pharmaceuticals Co., Ltd. · Updated on 2026-01-09
152
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled.
CONDITIONS
Official 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 time of consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapies, are intolerant to standard therapies, or have no standard therapies available
- Recurrent or refractory acute myeloid leukemia (AML) according to WHO 2016 criteria
- Life expectancy of at least 3 months
- At least one measurable lesion for solid tumor patients as defined by RECIST v1.1
- Sufficient baseline organ function
You will not qualify if you...
- History of a different cancer within the last 3 years
- Known serious allergy to the investigational drug or its excipients
- Active brain or spinal metastases
- History of pericarditis or Grade 2 or higher pericardial effusion
- History of interstitial lung disease
- Active infections of Grade 2 or higher within 2 weeks
- Known HIV infection
- Seropositive for hepatitis B virus
- Seropositive for hepatitis C virus or detectable HCV-RNA viral levels
- Severe or uncontrolled medical conditions
- History of myocardial infarction, unstable angina, coronary artery bypass graft, 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
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Trial Site Locations
Total: 1 location
1
Tianjin
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
Jacobio Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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