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

NCT05756153 | Completed Phase 1

• 1 other identifier: GFH925X0201
• Study Type: interventional
• Target: 47
• Locations: 3 countries
• Sites: 21

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

Conditions

Advance Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Phase Ib: adverse events

  defined as number of patients with treatment emergent AEs

  28 days

• Phase II: objective response rate

  defined as the percent of patients documented a PR/CR

  up to 1 year after last patient in

Study Arms (1)

GFH925+Cetuximab

EXPERIMENTAL

Drug: GFH925; Drug: Cetuximab

Interventions

GFH925 DRUG

GFH925 tablets administered orally daily.

GFH925+Cetuximab

Cetuximab DRUG

Cetuximab administered intravenously Q2W.

GFH925+Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genfleet Therapeutics (Shanghai) Inc.: lead

Study Sites (21)

University General Hospital "Attikon"

Athens, Haidari, 12462, Greece

Location

General Hospital of Athens "Alexandra"

Athens, Greece

Location

University General Hospital "Attikon"

Athens, Greece

Location

Bioclinic Thessaloniki

Thessaloniki, Greece

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, Emilia-Romagna, 40138, Italy

Location

IRCCS Centro di Riferimento Oncologico

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

IOV - Istituto Oncologico Veneto IRCCS

Padova, Friuli Venezia Giulia, 35218, Italy

Location

Istituto Nazionale Tumori Regina Elena IRCCS

Rome, Lazio, 00144, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Candiolo Cancer Institute, FPO-IRCCS

Candiolo, Piedmont, 10060, Italy

Location

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, Tuscany, 53100, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

Verona, Veneto, 37126, Italy

Location

ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica

Badalona, Barcelona, 08916, Spain

Location

Clinica Universidad de Navarra, Servicio de Oncologia

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari Dexeus,Servicio de Oncologia Medica

Barcelona, 08028, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Clinica Mi Tres Torres

Barcelona, 8017, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Regional Universitario de Malaga,Oncology Dept

Málaga, 29010, Spain

Location

Virgen del Rocio University Hospital

Seville, 41013, Spain

Location

Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica

Valencia, 46009, Spain

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 6, 2023
• Study Start: April 25, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

ES (9); GR (4); IT (8)