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NOT YET RECRUITING
NCT07616089
PHASE1

Phase I Study of FXS0683 in the Treatment of Blood Tumors

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

Summary

This is a first-in-human, multicenter, open-label, single-arm Phase I study of FXS0683 in participants with relapsed or refractory hematologic malignancies to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity, and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).

Official title: A Multicenter, Open, Single-arm Phase I Dose-escalation and Dose-expansion Clinical Study: Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of FXS0683 Tablets in Patients With Relapsed or Refractory Hematologic Malignancies.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2026-06-01

Completion Date

2029-08-08

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

FXS0683

FXS0683 is a potent and highly selective BCL-2 inhibitor

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)

Tianjin, Tianjin Municipality, China