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

Phase 1

Recruiting

• Conditions: Advance Non-small Cell Lung Cancer
• Interventions: Drug: GFH925; Drug: Cetuximab

• Registration Number: NCT05756153
• Lead Sponsor: Genfleet Therapeutics (Shanghai) Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2023-04-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-03
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Patient has provided informed consent form (ICF).
2. Males or females aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
4. Life expectancy > 3 months judged by the investigator.
5. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC.
6. Have at least one measurable lesion per RECIST 1.1.
7. Have sufficient organ functions.
8. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2).
9. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GFH925+Cetuximab	GFH925	-
GFH925+Cetuximab	Cetuximab	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (17)

University General Hospital "Attikon"; 🇬🇷 Athens, Haidari, Greece

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS; 🇮🇹 Bologna, Emilia-Romagna, Italy

IRCCS Centro di Riferimento Oncologico; 🇮🇹 Aviano, Friuli-Venezia Giulia, Italy

IOV - Istituto Oncologico Veneto IRCCS; 🇮🇹 Padova, Friuli-Venezia Giulia, Italy

Istituto Nazionale Tumori Regina Elena IRCCS; 🇮🇹 Roma, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Lombardia, Italy

Candiolo Cancer Institute, FPO-IRCCS; 🇮🇹 Candiolo, Piemonte, Italy

A.O.U. Senese Policlinico Santa Maria alle Scotte; 🇮🇹 Siena, Toscana, Italy

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma); 🇮🇹 Verona, Veneto, Italy

ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica; 🇪🇸 Barcelona, Spain

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