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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-014 | Other Identifier | MSD | |
| U1111-1320-8626 | Registry Identifier | UTN | |
| 2025-521737-91-00 | Registry Identifier | EU CT | |
| jRCT2031250825 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) |
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Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
The goals of this study are to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calderasib | Experimental | Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. |
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| Calderasib + Cetuximab | Experimental | Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. | Up to approximately 76 months |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported. | Up to approximately 76 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 76 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Baltimore Medical Center ( Site 1104) | Recruiting | Baltimore | Maryland | 21204 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Cetuximab | Biological | Intravenous administration |
|
| Up to approximately 76 months |
| Duration of Response (DOR) | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. | Up to approximately 76 months |
| Overall Survival (OS) | OS is defined as the time from randomization to the date of death due to any cause. OS will be presented. | Up to approximately 76 months |
| START Midwest ( Site 1103) | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Comprehensive Cancer Centers of Nevada ( Site 1109) | Recruiting | Las Vegas | Nevada | 89169 | United States |
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| Rutgers Cancer Institute of New Jersey ( Site 1100) | Recruiting | New Brunswick | New Jersey | 08903 | United States |
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| START Mountain Region ( Site 1106) | Recruiting | West Valley City | Utah | 84119 | United States |
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| Virginia Cancer Specialists ( Site 1102) | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Prince of Wales Hospital-Medical Oncology ( Site 1003) | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Westmead Hospital ( Site 1000) | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Epworth Freemasons ( Site 1004) | Recruiting | Melbourne | Victoria | 3002 | Australia |
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| Jewish General Hospital-CRU ( Site 2900) | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| FALP ( Site 1200) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Centro de Oncología de Precisión ( Site 1202) | Recruiting | Santiago | Region M. de Santiago | 7560908 | Chile |
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| Clinica San Carlos de Apoquindo ( Site 1203) | Recruiting | Santiago | Region M. de Santiago | 7620002 | Chile |
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| Bradfordhill ( Site 1201) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| Beijing Cancer hospital ( Site 1318) | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| The First Affiliated Hospital of Xiamen University ( Site 1304) | Recruiting | Xiamen | Fujian | 361003 | China |
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| Sun Yat-sen University Cancer Center ( Site 1303) | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| The first affiliated hospital, Sun Yat-Sen university ( Site 1329) | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Harbin Medical University Cancer Hospital ( Site 1308) | Recruiting | Harbin | Heilongjiang | 101149 | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1326) | Recruiting | Wuhan | Hubei | 430000 | China |
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| Jiangsu Province Hospital ( Site 1324) | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| Jinan Central Hospital ( Site 1313) | Recruiting | Jinan | Shandong | 250013 | China |
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| Shanghai Chest Hospital ( Site 1300) | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Fudan University Shanghai Cancer Center ( Site 1325) | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Zhongshan Hospital,Fudan University ( Site 1301) | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Zhejiang Cancer Hospital ( Site 1311) | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| Taizhou Hospital of Zhejiang Province ( Site 1312) | Recruiting | Linhai | Zhejiang | 317000 | China |
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| Rigshospitalet ( Site 1403) | Recruiting | Copenhagen | Capital Region | 2100 | Denmark |
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| Odense Universitetshospital ( Site 1401) | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
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| Universitätsklinikum Leipzig ( Site 1602) | Recruiting | Leipzig | Saxony | 04103 | Germany |
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| Universitätsklinikum Jena ( Site 1603) | Recruiting | Jena | Thuringia | 07747 | Germany |
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| General Hospital of Athens "Laiko" ( Site 1701) | Recruiting | Athens | Attica | 11527 | Greece |
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| European Interbalkan Medical Center-Oncology Department ( Site 1700) | Recruiting | Thessaloniki | 57001 | Greece |
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| Emek Medical Center ( Site 1800) | Recruiting | Afula | 1834111 | Israel |
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| Hadassah Medical Center ( Site 1801) | Recruiting | Jerusalem | 9112001 | Israel |
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| Sourasky Medical Center ( Site 1802) | Recruiting | Tel Aviv | 6423906 | Israel |
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| Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902) | Recruiting | Rozzano | Milano | 20089 | Italy |
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| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1900) | Recruiting | Milan | 20133 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1901) | Recruiting | Roma | 00168 | Italy |
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| National Cancer Center Hospital ( Site 2000) | Recruiting | Chūō | Tokyo | 104-0045 | Japan |
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| Cancer Institute Hospital of JFCR ( Site 2003) | Recruiting | Koto | Tokyo | 135-8550 | Japan |
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| Haukeland universitetssykehus ( Site 2102) | Recruiting | Bergen | Hordaland | 5021 | Norway |
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| Oslo universitetssykehus, Radiumhospitalet ( Site 2101) | Recruiting | Oslo | 0379 | Norway |
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| MTZ Clinical Research powered by Pratia ( Site 2205) | Recruiting | Warsaw | Masovian Voivodeship | 02-172 | Poland |
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| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2200) | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
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| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 2203) | Recruiting | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
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| Seoul National University Hospital ( Site 2301) | Recruiting | Seoul | 03080 | South Korea |
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| Asan Medical Center ( Site 2302) | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center ( Site 2300) | Recruiting | Seoul | 06351 | South Korea |
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| Hospital Virgen de la Victoria ( Site 2403) | Recruiting | Málaga | Malaga | 29010 | Spain |
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| Hospital Universitari Vall d Hebron ( Site 2401) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Clinic de Barcelona ( Site 2402) | Recruiting | Barcelona | 08036 | Spain |
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| Hospital Clinico San Carlos ( Site 2404) | Recruiting | Madrid | 28040 | Spain |
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| Karolinska Universitetssjukhuset Solna ( Site 2501) | Recruiting | Stockholm | Stockholm County | 171 64 | Sweden |
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| Sahlgrenska Universitetssjukhuset. ( Site 2502) | Recruiting | Gothenburg | Västra Götaland County | 413 45 | Sweden |
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| Adana Medical Park Seyhan Hastanesi ( Site 2706) | Recruiting | Adana | 01140 | Turkey (Türkiye) |
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| Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2702) | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
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| Ankara Bilkent Şehir Hastanesi ( Site 2701) | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
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| Hacettepe Universitesi-oncology hospital ( Site 2700) | Recruiting | Ankara | 6230 | Turkey (Türkiye) |
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| Koc University Hospital ( Site 2704) | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
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| Royal Free Hospital ( Site 2801) | Recruiting | London | Camden | NW3 2QG | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 2803) | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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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