NCT06435455

GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GH21 Capsule Combined With D-1553 Tablets in Patients With Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Suzhou Genhouse Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.

Detailed description

This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.

Conditions

• Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

Interventions

Type	Name	Description
DRUG	GH21	GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule
DRUG	D-1553	D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2024-05-30
• Last updated: 2024-07-08