A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors
This study tests a new drug called GW5282 in people with advanced solid tumors that have spread or cannot be completely removed by surgery. Researchers will first test different doses to find the safest and most effective dose, then study how well the drug works in a larger group of patients.
Key Objective: The trial is testing whether GW5282 can safely shrink or slow the growth of advanced solid tumors.
Who to Consider: People with locally advanced or metastatic solid tumors who have exhausted standard treatment options may want to consider enrolling.
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. All participants must provide a signed, dated written informed consent (ICF) prior to any study-specific procedures, sampling, and analysis. 2. Male and female participants must be ≥18 years of age at the time of signing the ICF. 3. Eastern Cooperative Oncology Group performance status of 0-1. 4. Histologically or cytologically confirmed locally advanced or metastatic solid tumors who has failed standard of cares (SoCs). 5. Life expectancy ≥3 months. 6. At least one measurable lesion according to RECIST 1.1. 7. Tumor tissue sample requirements: sections of formalin-fixed paraffin-embedded (FFPE) tissue from freshly obtained biopsy sample or archived tumor sample. 8. Adequate organ and marrow function. 9. Participants should be able to comply with the requirements of this study for medication use and follow-up. 10. 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 donati