A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Sponsor

Zhejiang Genfleet Therapeutics Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756153

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC

Condition or Disease	Intervention/Treatment	Phase
Advance Non-small Cell Lung Cancer	Drug: GFH925 Drug: Cetuximab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GFH925+Cetuximab	Drug: GFH925 GFH925 tablets administered orally daily. Drug: Cetuximab Cetuximab administered intravenously Q2W.

Arm

Intervention/Treatment

Experimental: GFH925+Cetuximab

Drug: GFH925

GFH925 tablets administered orally daily.

Drug: Cetuximab

Cetuximab administered intravenously Q2W.

Outcome Measures

Primary Outcome Measures

Phase Ib: adverse events [28 days]
defined as number of patients with treatment emergent AEs
Phase II: objective response rate [up to 1 year after last patient in]
defined as the percent of patients documented a PR/CR

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient has provided informed consent form (ICF).
Males or females aged ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
Life expectancy > 3 months judged by the investigator.
Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
Have at least one measurable lesion per RECIST 1.1.
Have sufficient organ functions.
With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period.

Exclusion Criteria:

With clinically significant cardiovascular diseases.
With active central nervous system (CNS) metastases and/or carcinomatous meningitis.
With clinically significant gastrointestinal diseases.
With active infections.
With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.
With uncontrolled systemic diseases, such as hypertension or diabetes.
Prior treatment with an inhibitor specific to KRAS G12C.
Major surgery within 4 weeks prior to initiation of study treatment.
With known allergies to the study drugs or components.
Pregnant or lactating females, or female patients intend to become pregnant during participation.

Contacts and Locations

Locations

No locations specified.

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:

NCT05756153

Other Study ID Numbers:

GFH925X0201

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Cetuximab

Study Results

No Results Posted as of Mar 9, 2023