A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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 0-1.
Histologically or cytologically confirmed locally advanced or metastatic solid tumors who has failed standard of cares (SoCs).
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- GW5282
- GW5282
Treatment groups
203 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov