A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

• Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05005234
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

Phase I: To evaluate the safety and tolerability of GFH925 in subjects with KRAS G12C mutant advanced solid tumors and estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D).Phase II: To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

Condition or Disease	Intervention/Treatment	Phase
KRAS G12C	Drug: GFH925	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations
• Actual Study Start Date: Sep 10, 2021
• Anticipated Primary Completion Date: Jan 10, 2024
• Anticipated Study Completion Date: Apr 10, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: GFH925 Phase I Dose Escalation Subjects with advanced NSCLC and gastrointestinal tumors will be enrolled in dose escalation cohorts based on Bayesian optimal interval (BOIN) design. Phase I Dose Expansion Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with responsive groups consisting of subjects with KRAS G12C mutant advanced NSCLC. Dose expansion may be done concurrently. Phase 2 Subjects with advanced NSCLC will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.

Drug: GFH925; Administered as an oral tablet formulation

Outcome Measures

Primary Outcome Measures

1. Number of subjects with dose-limiting toxicities (DLTs) [Baseline to 24 Months]

Secondary Outcome Measures

1. Objective response rate (ORR) as assessed by RECIST 1.1 criteria [Baseline to 24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men or women ≥18 years old

• Pathologically diagnosed, previously treated, advanced tumor with KRAS p.G12C mutation

• Adequate organ function

• Measurable disease per RECIST 1.1 criteria.

Exclusion Criteria:

• Significant concomitant diseases

• Active brain metastases

• Previous treatment with KRAS G12C inhibitor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Zhejiang Genfleet Therapeutics Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Genfleet Therapeutics Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05005234
• Other Study ID Numbers: GFH925X1101
• First Posted: Aug 13, 2021
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 3, 2022