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Brief Title: A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
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
Study ID: NCT04686682
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. 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.
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-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced malignant tumors. To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc).To evaluate preliminary antitumor activity of JAB-8263
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tianjin, Tianjin, Tianjin, China
Name: Jacobio Pharmaceuticals
Affiliation: Jacobio Pharmaceuticals
Role: STUDY_DIRECTOR