NCT06329206 A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
| NCT ID | NCT06329206 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Genhouse Bio Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2026-04-25 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
Eligibility Criteria
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Men or women ≥18 years old. 2. The following two points are evaluated by the Investigator and are deemed suitable to participate in the study: a. The subject fully understands the requirements of the study and voluntarily signs the written informed consent; b. Be able to comply with the medication requirements of the study and all study related procedures and evaluations. 3. Meeting the requirements of tumor types shown below: Phase Ia Study: Subjects with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy. The specific tumor types include but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), triple-negative breast cancer (TNBC), bladd