GH21 Combined With D-1553 With Advanced Solid Tumors

KRAS G12C Mutant Solid Tumors Clinical Trial

Official title: A Multicenter, Open-label Phase Ib/II Clinical 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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• KRAS G12C Mutant Solid Tumors
• Neoplasms

• NCT number: NCT06435455
• Study type: Interventional
• Source: Suzhou Genhouse Bio Co., Ltd.
• Contact: Jieqi Tang, bachelor
• Phone: +8613311557758
• Email: tangjieqi@genhousebio.com
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2024
• Completion date: December 31, 2027