Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07328217
PHASE1/PHASE2

A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase 1/2, open-label, multicenter study assessing the safety, tolerability, pharmacokinetics and efficacy of GW5282 in participants with locally advanced or metastatic solid tumors. This study comprised of a dose escalation phase to determine the MTD and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of GW5282.

Official title: A Phase 1/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of GW5282 in Participants With Advanced Solid Tumors (BEI-DOU2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

203

Start Date

2026-01-29

Completion Date

2029-06

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

GW5282

Single dose period (only for dose escalation phase): administered one single dose at assigned dose level orally. Repeated does period (for dose escalation phase and dose expansion phase): administered at assigned dose levels and schedules twice daily (BID) orally in 21-day cycles continuously.

DRUG

GW5282

RDFE will be determined by dose escalation phase.

Locations (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China