NCT07328217
Recruiting
Phase 1
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)
Dizal Pharmaceuticals3 sites in 1 country203 target enrollmentStarted: January 29, 2026Last updated:
InterventionsGW5282
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Dizal Pharmaceuticals
- Enrollment
- 203
- Locations
- 3
- Primary Endpoint
- Incidence of Dose Limiting Toxicities (DLTs) (Dose Escalation only)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All participants must provide a signed, dated written informed consent (ICF) prior to any study-specific procedures, sampling, and analysis.
- •Male and female participants must be ≥18 years of age at the time of signing the ICF.
- •Eastern Cooperative Oncology Group performance status of 0-
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors who has failed standard of cares (SoCs).
- •Life expectancy ≥3 months.
- •At least one measurable lesion according to RECIST 1.
- •Tumor tissue sample requirements: sections of formalin-fixed paraffin-embedded (FFPE) tissue from freshly obtained biopsy sample or archived tumor sample.
- •Adequate organ and marrow function.
- •Participants should be able to comply with the requirements of this study for medication use and follow-up.
- •If the female partner of a male participant has a potential for pregnancy, he must agree to use contraception (such as condoms) and refrain from donating sperm during the treatment period and for at least 6 months after the last dose of study treatment.
Exclusion Criteria
- •Any unresolved \> grade 1 (according to CTCAE version 5.0) adverse event (excluding alopecia, anemia, neutropenia, and thrombocytopenia) prior to the first administration of investigational drug.
- •Any known active central nervous system metastases and/or carcinomatous meningitis and/or spinal cord compression.
- •Having any of the following treatment history:
- •previously treated with GW5282 or other EZH pathway inhibitors.
- •previously received any cytotoxic chemotherapy, investigational drug, or other anticancer drug (excluding macromolecular drugs) or clinical trial within 7 days or 5 half-lives (whichever is longer) prior to the first administration of the investigational drug.
- •previously received any macromolecular drug (such as immunotherapy, monoclonal antibodies, bispecific antibodies, or antibody-drug conjugates) within 28 days prior to the first administration of the investigational drug.
- •Underwent major surgery (excluding vascular access surgery) or suffered severe trauma within 4 weeks prior to the first administration of the investigational drug.
- •Received limited field of radiation to alleviate symptoms within 7 days prior to the first administration of the investigational drug, or received more than 30% or extensive field of radiation to the bone marrow within 28 days prior to the first administration of the investigational drug.
- •Received live-attenuated vaccine or viral vector vaccine within 4 weeks prior to the first administration of the investigational drug."
- •Active infectious diseases.
Arms & Interventions
Dose Escalation Phase
Experimental
Escalating doses of GW5282 administered orally
Intervention: GW5282 (Drug)
Dose Expansion phase
Experimental
The recommended dose(s) for expansion (RDFE) for GW5282 from dose escalation phase will be evaluated in selected tumors.
Intervention: GW5282 (Drug)
Outcomes
Primary Outcomes
Incidence of Dose Limiting Toxicities (DLTs) (Dose Escalation only)
Time Frame: Up to 21 days
Number of participants with Adverse Events (AEs)
Time Frame: Approximately 24 months from first participant enrolled
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Approximately 24 months from first participant enrolled
Overall Response Rate (ORR)
Time Frame: Approximately 24 months from first participant enrolled
ORR is defined as the percentage of subjects with Best Response of Complete Response (CR) or Partial Response (PR) as determined by the investigator
Secondary Outcomes
- Cmax; Maximum Plasma Concentration of GW5282(Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose)
- AUCss; Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady State of GW5282(Cycle 1 Day 15: 0 (predose) up to 12 hours post-dose)
- AUC; Area Under the Plasma Concentration-time Curve of GW5282(Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose)
- Tmax; Time to Reach Maximum Plasma Concentration (Cmax) of GW5282(Single dose period (only for dose escalation phase): 0 (predose) up to 72 hours post-dose)
- Css,max; Maximum Steady State Plasma Concentration of GW5282(Cycle 1 Day 15: 0 (predose) up to 12 hours post-dose)
- Duration of response (DOR)(Approximately 24 months from first participant enrolled)
- Tss,max; Time to Reach Maximum Plasma Concentration (Cmax) at Steady State of GW5282(Cycle 1 Day 15: 0 (predose) up to 12 hours post-dose)
- Disease Control Rate (DCR)(Approximately 24 months from first participant enrolled)
- Progression-free survival (PFS)(Approximately 24 months from first participant enrolled)
Investigators
Study Sites (3)
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