NCT06310382 GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
| NCT ID | NCT06310382 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Genhouse Bio Co., Ltd. |
| Condition | Advanced Solid Tumors With MAPK Signal Pathway Mutations |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-12-07 |
| Primary Completion | 2025-05-26 |
Trial Parameters
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Brief Summary
This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors. This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.
Eligibility Criteria
Inclusion Criteria: Subjects must meet all the following inclusion criteria to be qualified for study enrollment: 1. Male or female subjects aged 18-80 years (inclusive). 2. Patients with histologically or cytologically confirmed MAPK mutant (presence of RAS/RAF/MEK/ERK mutations) locally advanced or metastatic solid tumors. 3. Patients who have failed standard treatment or have no standard treatment regimen or are not suitable for standard treatment currently. 4. Dose escalation: At least one assessable tumor lesion according to RECIST version 1.1; Dose expansion: At least one measurable tumor lesion according to RECIST version 1.1 (tumor lesion located in the region of previous radiotherapy or other locoregional treatment sites is usually not considered a measurable lesion, unless this lesion shows clear progression or persists for 3 months after radiotherapy). 5. Eastern Cooperative Oncology Group (ECOG) performance status score: Phase I dose escalation: 0-1. Phase II dose expansion