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A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
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. 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2021-05-07
Completion Date
2028-07
Last Updated
2026-01-09
Healthy Volunteers
No
Interventions
JAB-8263
Variable dose, orally Q2D with 28 days each cycle
JAB-8263
RP2D dose, orally Q2D with 28 days each cycle
Locations (1)
Tianjin
Tianjin, Tianjin Municipality, China