Trial Title:
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
NCT ID:
NCT05756153
Condition:
Advance Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Cetuximab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GFH925
Description:
GFH925 tablets administered orally daily.
Arm group label:
GFH925+Cetuximab
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Cetuximab administered intravenously Q2W.
Arm group label:
GFH925+Cetuximab
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University General Hospital "Attikon"
Address:
City:
Athens
Zip:
12462
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Anna Koumarianou
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefania Salvagni
Facility:
Name:
IRCCS Centro di Riferimento Oncologico
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa De Carlo
Facility:
Name:
IOV - Istituto Oncologico Veneto IRCCS
Address:
City:
Padova
Zip:
35218
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Valentina Guarneri
Facility:
Name:
Istituto Nazionale Tumori Regina Elena IRCCS
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federico Cappuzzo
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Lo Russo
Facility:
Name:
Candiolo Cancer Institute, FPO-IRCCS
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vanesa Gregorc
Facility:
Name:
A.O.U. Senese Policlinico Santa Maria alle Scotte
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Maio
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Michele Milella
Facility:
Name:
ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Teresa Moran Bueno
Facility:
Name:
Clinica Universidad de Navarra, Servicio de Oncologia
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Miguel Fernandez de Sanmamed Gutierrez
Facility:
Name:
Hospital Universitari Dexeus,Servicio de Oncologia Medica
Address:
City:
Barcelona
Zip:
08028
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Gonzalez Cao
Facility:
Name:
ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Margarita Majem Tarruella
Facility:
Name:
Clinica Mi Tres Torres
Address:
City:
Barcelona
Zip:
8017
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Viteri Santiago
Phone:
0034 932287445
Email:
sviteri@uomi.es
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Enriqueta Felip Font
Facility:
Name:
Hospital Regional Universitario de Malaga,Oncology Dept
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Vanesa Gutierrez Calderon
Facility:
Name:
Virgen del Rocio University Hospital
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Reyes Bernabe Caro
Facility:
Name:
Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ignacio Gil Bazo
Start date:
April 25, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Zhejiang Genfleet Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Genfleet Therapeutics (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756153
