Advance Non-small Cell Lung CancerPhase 1/2NCT05756153
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
A Phase 1/2 study testing GFH925 and Cetuximab in people with Advance Non-small Cell Lung Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 21 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Non-small Cell Lung Cancer
- What is being tested?
- GFH925 and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 25 Apr 2023to 30 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Spain9 sites
ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica
Badalona, Barcelona, 08916
Hospital Universitari Dexeus,Servicio de Oncologia Medica
Barcelona, 08028
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Clinica Mi Tres Torres
Barcelona, 8017
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Regional Universitario de Malaga,Oncology Dept
Málaga, 29010
Clinica Universidad de Navarra, Servicio de Oncologia
Pamplona, Navarre, 31008
Virgen del Rocio University Hospital
Seville, 41013
Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica
Valencia, 46009
Italy8 sites
IRCCS Centro di Riferimento Oncologico
Aviano, Friuli Venezia Giulia, 33081
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Emilia-Romagna, 40138
Candiolo Cancer Institute, FPO-IRCCS
Candiolo, Piedmont, 10060
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
IOV - Istituto Oncologico Veneto IRCCS
Padova, Friuli Venezia Giulia, 35218
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, 00144
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Tuscany, 53100
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, Veneto, 37126
Greece4 sites
University General Hospital "Attikon"
Athens, Haidari, 12462
General Hospital of Athens "Alexandra"
Athens
University General Hospital "Attikon"
Athens
Bioclinic Thessaloniki
Thessaloniki
About this study
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
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
- Being tested
- GFH925, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFH925Drug
GFH925 tablets administered orally daily.
CetuximabDrug
Cetuximab administered intravenously Q2W.
| Study group | Role | What they receive |
|---|---|---|
| GFH925+Cetuximab | Experimental | Not described Receives: Drug: GFH925; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: adverse events
defined as number of patients with treatment emergent AEs
Measured: 28 days
Phase II: objective response rate
defined as the percent of patients documented a PR/CR
Measured: up to 1 year after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start25 Apr 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Genfleet Therapeutics (Shanghai) Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756153
- Sponsor's protocol ID
- GFH925X0201
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gregorc V, Majem M, Lo Russo G, Maio M, Salvagni S, Gutierrez-Calderon V, Gonzalez-Cao M, Sandiego Contreras S, Koumarianou A, Bearz A, Bernabe-Caro R, Viteri S, de Sanmamed MF, Zagouri F, Moran Bueno T, Lazzari C, Martinez-Recio S, Gimenez-Capitan A, Zhang Y, Shan Y, Zhu H, Zhao C, Shen H, Wang Y, Rosell R. Fulzerasib plus cetuximab in first-line KRASG12C-mutated non-small-cell lung cancer (KROCUS): a single-arm, multicentre, phase 1b/2 trial. Lancet Oncol. 2026 Apr;27(4):432-441. doi: 10.1016/S1470-2045(25)00764-8.
PubMed 41926959
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05756153
- Acronym / sponsor ID
- GFH925X0201
- Conditions
- Advance Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GFH925+Cetuximab | Experimental | Drug: GFH925, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFH925GFH925 tablets administered orally daily. | Drug | GFH925+Cetuximab |
| CetuximabCetuximab administered intravenously Q2W. | Drug | GFH925+Cetuximab |
Primary outcome
Phase Ib: adverse events
Time frame: 28 days
defined as number of patients with treatment emergent AEs
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 41926959Gregorc V, Majem M, Lo Russo G, Maio M, Salvagni S, Gutierrez-Calderon V, Gonzalez-Cao M, Sandiego Contreras S, Koumarianou A, Bearz A, Bernabe-Caro R, Viteri S, de Sanmamed MF, Zagouri F, Moran Bueno T, Lazzari C, Martinez-Recio S, Gimenez-Capitan A, Zhang Y, Shan Y, Zhu H, Zhao C, Shen H, Wang Y, Rosell R. Fulzerasib plus cetuximab in first-line KRASG12C-mutated non-small-cell lung cancer (KROCUS): a single-arm, multicentre, phase 1b/2 trial. Lancet Oncol. 2026 Apr;27(4):432-441. doi: 10.1016/S1470-2045(25)00764-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GFH925 and Cetuximab in people with Advance Non-small Cell Lung Cancer, run by Genfleet Therapeutics (Shanghai) Inc. at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Italy, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: adverse events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.