A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
Condition(s) studied
Investigational drug(s) / intervention(s)
Calderasib: Oral dose
Pembrolizumab: Intravenous infusion of 200 mg
carboplatin: Per label
pemetrexed: Per label
cetuximab: Per label
oxaliplatin: Per label
leucovorin: Per label
5-fluorouracil: Per label
Study summary
This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.
Eligibility
Primary outcome measure(s)
- Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) — Up to ~21 days
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT will be reported. - Number of Participants Who Experience an Adverse Event (AE) — Up to ~56 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be reported. - Number of Participants Who Discontinue Study Treatment Due to an AE — Up to ~56 months
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported.
Trial sites (75)
| Facility | City | Region | Status |
|---|---|---|---|
| Moffitt Cancer Center ( Site 0261) | Tampa | Florida | Recruiting |
| START Midwest ( Site 0267) | Grand Rapids | Michigan | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260) | Hackensack | New Jersey | Recruiting |
| Laura and Isaac Perlmutter Cancer Center ( Site 0270) | New York | New York | Completed |
| NEXT Virginia ( Site 0271) | Fairfax | Virginia | Recruiting |
| MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262) | Milwaukee | Wisconsin | Recruiting |
| Instituto Alexander Fleming ( Site 0434) | Ciudad Autónoma de Buenos Aires | Buenos Aires | Recruiting |
| Sanatorio Parque ( Site 0456) | Rosario | Santa Fe Province | Recruiting |
| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438) | La Rioja | Argentina | Recruiting |
| Chris O'Brien Lifehouse ( Site 0002) | Camperdown | New South Wales | Recruiting |
| Liverpool Hospital-Medical Oncology ( Site 0001) | Liverpool | New South Wales | Recruiting |
| Westmead Hospital ( Site 0006) | Westmead | New South Wales | Recruiting |
| Monash Health-Oncology Research ( Site 0003) | Clayton | Victoria | Recruiting |
| Cross Cancer Institute ( Site 0033) | Edmonton | Alberta | Recruiting |
| The Moncton Hospital ( Site 0037) | Moncton | New Brunswick | Recruiting |
| Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030) | Hamilton | Ontario | Recruiting |
| Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036) | Kingston | Ontario | Recruiting |
| Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032) | Toronto | Ontario | Recruiting |
| James Lind Centro de Investigacion del Cancer ( Site 0043) | Temuco | Araucania | Completed |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041) | Santiago | Region M. de Santiago | Recruiting |
| FALP-UIDO ( Site 0040) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 0042) | Santiago | Region M. de Santiago | Recruiting |
| Beijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417) | Beijing | Beijing Municipality | Recruiting |
| Fujian Cancer Hospital ( Site 0419) | Fuzhou | Fujian | Recruiting |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413) | Guangzhou | Guangdong | Recruiting |
| Sun Yat-sen University Cancer Center-Internal medicine ( Site 0415) | Guangzhou | Guangdong | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418) | Wuhan | Hubei | Recruiting |
| Jilin Cancer Hospital-oncology department ( Site 0412) | Changchun | Jilin | Completed |
| Shanghai Chest Hospital-Oncology department ( Site 0410) | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai East Hospital ( Site 0416) | Shanghai | Shanghai Municipality | Recruiting |
| Zhejiang Cancer Hospital-Thoracic oncology ( Site 0411) | Hangzhou | Zhejiang | Recruiting |
| Odense Universitetshospital-Department of oncology ( Site 0421) | Odense | Region Syddanmark | Recruiting |
| Rambam Health Care Campus-Oncology ( Site 0090) | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center-Oncology ( Site 0092) | Jerusalem | Israel | Recruiting |
| Hadassah Medical Center-Oncology ( Site 0094) | Jerusalem | Israel | Recruiting |
| Meir Medical Center. ( Site 0091) | Kfar Saba | Israel | Recruiting |
| Sheba Medical Center-ONCOLOGY ( Site 0093) | Ramat Gan | Israel | Recruiting |
| Humanitas ( Site 0113) | Rozzano | Lombardy | Recruiting |
| ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111) | Siena | Tuscany | Recruiting |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110) | Naples | Italy | Recruiting |
+ 35 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05067283 on ClinicalTrials.gov ↗ ← All trials in Poland