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

NCT07328217 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2026-02-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dizal Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Mengzhao Wang · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07328217 on ClinicalTrials.gov