NCT07328217

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

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-29
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2026-01-09
• Last updated: 2026-02-11

Locations

3 sites across 1 country: China