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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFH925+Cetuximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFH925 | Drug | GFH925 tablets administered orally daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital "Attikon" | Athens | Haidari | 12462 | Greece | ||
| General Hospital of Athens "Alexandra" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41926959 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2026 | |
| Reset | May 1, 2026 |
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| Cetuximab |
| Drug |
Cetuximab administered intravenously Q2W. |
|
| Athens |
| Greece |
| University General Hospital "Attikon" | Athens | Greece |
| Bioclinic Thessaloniki | Thessaloniki | Greece |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS | Bologna | Emilia-Romagna | 40138 | Italy |
| IRCCS Centro di Riferimento Oncologico | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| IOV - Istituto Oncologico Veneto IRCCS | Padova | Friuli Venezia Giulia | 35218 | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS | Rome | Lazio | 00144 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Candiolo Cancer Institute, FPO-IRCCS | Candiolo | Piedmont | 10060 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | Tuscany | 53100 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) | Verona | Veneto | 37126 | Italy |
| ICO Badalona - Hospital Universitari Germans Trias i Pujol,Servicio de Oncologia Medica | Badalona | Barcelona | 08916 | Spain |
| Clinica Universidad de Navarra, Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Dexeus,Servicio de Oncologia Medica | Barcelona | 08028 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Clinica Mi Tres Torres | Barcelona | 8017 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Regional Universitario de Malaga,Oncology Dept | Málaga | 29010 | Spain |
| Virgen del Rocio University Hospital | Seville | 41013 | Spain |
| Instituto Valenciano de Oncologia IVO,Servicio de Oncologia Medica | Valencia | 46009 | Spain |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2026 | May 1, 2026 |
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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