NCT06796699

A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

A Multi-center, Single-Arm, Open-Label Phase Ia/Ib Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Suzhou Genhouse Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).

Conditions

• Advanced Solid Tumors With MTAP Gene Deletion

Interventions

Type	Name	Description
DRUG	GH56 Capsule	GH56 capsule for oral administration at specified doses on scheduled days.

Timeline

• Start date: 2025-03-07
• Primary completion: 2027-12-31
• Completion: 2028-02-29
• First posted: 2025-01-28
• Last updated: 2025-03-28

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study