drugset / Trial / NCT07446725
A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors
Phase 1/2
Not yet recruiting
152 enrolled
Suzhou Genhouse Bio Co., Ltd.
Shanghai Goboard Cancer Hospital · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms. This study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.
Timeline
- Start
- 2026-02-24
- Primary completion
- 2029-10-30
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GH21 | Unknown | — | Oral |
| Subject | GH55 | Small molecule | — | Oral |
Indications
No indication recorded.