NCT07156253 Study of SYN818 With Olaparib for the Treatment of Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT07156253 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd |
| Condition | Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2028-08-25 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 with Olaparib in adult patients with locally advanced or metastatic solid tumors
Eligibility Criteria
Inclusion Criteria: * Having signed the written Informed Consent Form (ICF); * Male or female aged ≥18 years; * Life expectancy ≥12 weeks; * Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1; * Participant has a histologically confirmed diagnosis of advanced or metastatic solid tumor and has exhausted all standard-of-care treatment options, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 1). * Participant has histologically or cytologically confirmed locally advanced or metastatic epithelial ovarian cancer or HER2-negative breast cancer, with documented BRCA mutations and/or homologous recombination repair deficiency (Part 2). * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; * No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease; * Adequate organ function and bone marrow function. Exclusion Criteria: * Previous or current use