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

March 7, 2024 updated by: Zhejiang Genfleet Therapeutics Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Haidari
      • Athens, Haidari, Greece, 12462
        • Recruiting
        • University General Hospital "Attikon"
        • Contact:
          • Anna Koumarianou
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
        • Contact:
          • Stefania Salvagni
    • Friuli-Venezia Giulia
      • Aviano, Friuli-Venezia Giulia, Italy, 33081
        • Recruiting
        • IRCCS Centro di Riferimento Oncologico
        • Contact:
          • Elisa De Carlo
      • Padova, Friuli-Venezia Giulia, Italy, 35218
        • Recruiting
        • IOV - Istituto Oncologico Veneto IRCCS
        • Contact:
          • Valentina Guarneri
    • Lazio
      • Roma, Lazio, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena IRCCS
        • Contact:
          • Federico Cappuzzo
    • Lombardia
      • Milano, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Contact:
          • Giuseppe Lo Russo
    • Piemonte
      • Candiolo, Piemonte, Italy, 10060
        • Recruiting
        • Candiolo Cancer Institute, FPO-IRCCS
        • Contact:
          • Vanesa Gregorc
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Recruiting
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
        • Contact:
          • Michele Maio
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
        • Contact:
          • Michele Milella
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Enriqueta Felip Font
      • Barcelona, Spain, 8017
        • Recruiting
        • Clínica Mi Tres Torres
        • Contact:
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Dexeus,Servicio de Oncologia Medica
        • Contact:
          • Maria Gonzalez Cao
      • Barcelona, Spain, 08041
        • Recruiting
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
        • Contact:
          • Margarita Majem Tarruella
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga,Oncology Dept
        • Contact:
          • Maria Vanesa Gutierrez Calderon
      • Sevilla, Spain, 41013
        • Recruiting
        • Virgen del Rocio University Hospital
        • Contact:
          • Reyes Bernabe Caro
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica
        • Contact:
          • Ignacio Gil Bazo
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
        • Contact:
          • Teresa Moran Bueno
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra, Servicio de Oncologia
        • Contact:
          • Miguel Fernandez de Sanmamed Gutierrez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Genfleet Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFH925X0201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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