drugset / Trial / NCT06310382
GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results
Phase 1/2
Recruiting
110 enrolled
Suzhou Genhouse Bio Co., Ltd.
Shandong Tumor Hospital · collabShanghai East Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-12-07
- Primary completion
- 2025-05-26
- Completion
- 2025-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GH55 | Small molecule | 40 mg | Oral |
| Subject | GH55 | Small molecule | 80 mg | Oral |
| Subject | GH55 | Small molecule | 150 mg | Oral |
| Subject | GH55 | Small molecule | 200 mg | Oral |
| Subject | GH55 | Small molecule | 250 mg | Oral |
Indications
No indication recorded.