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RECRUITING
NCT04686682
PHASE1/PHASE2

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

JAB-8263

Variable dose, orally Q2D with 28 days each cycle

DRUG

JAB-8263

RP2D dose, orally Q2D with 28 days each cycle

Locations (1)

Tianjin

Tianjin, Tianjin Municipality, China