NCT07446725

A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors

Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of GH55 Capsule in Combination With GH21 Capsule in Subjects With Locally Advanced or Metastatic Solid Tumors Harboring Aberrantly Activated MAPK Signaling Pathway.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Suzhou Genhouse Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	Phase I dose escalation	Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 following a dose-escalation design until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.
DRUG	Phase I: Dose Expansion	Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at two dose levels established in the Dose Escalation phase until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.
DRUG	phase II	Drug: GH55 Drug: GH21 Treatment Group: Subjects will receive oral GH55 and GH21 at the fixed dose established during the Phase I portion until confirmed disease progression, unacceptable toxicity, or fulfillment of any study withdrawal criterion.

Timeline

• Start date: 2026-02-24
• Primary completion: 2029-10-30
• Completion: 2029-12-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: China