NCT05067283Recrutement en cours
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
Résumé
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.
Critères d'inclusion
For all participants: • Has measurable disease by RECIST 1.1 criteria • Has adequate organ function • Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic • Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease For Arm 2 \- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% For Arm 3 • Has locally advanced unresectable or metastatic solid-tumor malignancy with histological or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC • Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample • Previous treatment failure of at least 1 line of systemic therapy Expansion Group B • Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation Arm 5 only • Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation • Previous treatment failure of one or 2 previous line(s) of systemic therapy Arm 6 only \- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
Critères d'exclusion
• Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention • Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years • Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis • Has an active infection requiring systemic therapy • Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection • Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis • Has an active autoimmune disease requiring systemic therapy • Has not fully recovered from any effects of major surgical procedure without significant detectable infection • Has one or more of the following ophthalmological findings/conditions: intraocular pressure \>21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease excluding age-related macular degeneration • Has received live or live-attenuated vaccine within 4 weeks of study start Arm 4 Only • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \[for example, piroxicam\]) before, during, and for at least 2 days after administration of pemetrexed. • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 1
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Italie, États-Unis, Argentine, Australie, Canada, Chili, Chine, Danemark, Israël, Japon, Lituanie, Malaisie, Nouvelle-Zélande, Panama, Pologne, Corée du Sud, Espagne, Taïwan, Turquie, Ukraine
- Promoteur
- Merck Sharp & Dohme LLC(Industrie)
- N° de protocole
- 1084-001
- Pathologies
- Advanced Solid Tumors
- Interventions
- Médicament, Biologique
Traitements évalués
- Calderasib
- Pembrolizumab
- carboplatin
- pemetrexed
- cetuximab
- oxaliplatin
- leucovorin
- 5-fluorouracil
Lieux · 67
- Sankt Gallen, SuisseCantonal Hospital St.Gallen ( Site 0224)Recrute dans ce centre
- Bellinzona, SuisseOspedale Regionale Bellinzona e Valli ( Site 0220)Recrute dans ce centre
- Rozzano, ItalieHumanitas ( Site 0113)Recrute dans ce centre
- Siena, Italieospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 0111)Recrute dans ce centre
- Naples, ItalieIstituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0110)Recrute dans ce centre
- Tampa, États-UnisMoffitt Cancer Center ( Site 0261)Recrute dans ce centre
- Grand Rapids, États-UnisSTART Midwest ( Site 0267)Recrute dans ce centre
- Hackensack, États-UnisJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)Recrute dans ce centre
- Fairfax, États-UnisNEXT Virginia ( Site 0271)Recrute dans ce centre
- Milwaukee, États-UnisMEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)Recrute dans ce centre
- Ciudad Autónoma de Buenos Aires, ArgentineInstituto Alexander Fleming ( Site 0434)Recrute dans ce centre
- Rosario, ArgentineSanatorio Parque ( Site 0456)Recrute dans ce centre
- La Rioja, ArgentineFundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)Recrute dans ce centre
- Camperdown, AustralieChris O'Brien Lifehouse ( Site 0002)Recrute dans ce centre
- Liverpool, AustralieLiverpool Hospital-Medical Oncology ( Site 0001)Recrute dans ce centre
- Westmead, AustralieWestmead Hospital ( Site 0006)Recrute dans ce centre
- Clayton, AustralieMonash Health-Oncology Research ( Site 0003)Recrute dans ce centre
- Edmonton, CanadaCross Cancer Institute ( Site 0033)Recrute dans ce centre
- Moncton, CanadaThe Moncton Hospital ( Site 0037)Recrute dans ce centre
- Hamilton, CanadaHamilton Health Sciences-Juravinski Cancer Centre ( Site 0030)Recrute dans ce centre
- Kingston, CanadaKingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036)Recrute dans ce centre
- Toronto, CanadaPrincess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032)Recrute dans ce centre
- Santiago, ChiliCentro de Estudios Clínicos SAGA-CECSAGA ( Site 0041)Recrute dans ce centre
- Santiago, ChiliFALP-UIDO ( Site 0040)Recrute dans ce centre
- Santiago, ChiliBradfordhill ( Site 0042)Recrute dans ce centre
- Beijing, ChineBeijing Friendship Hospital Affiliate of Capital University-Oncology ( Site 0417)Recrute dans ce centre
- Fuzhou, ChineFujian Cancer Hospital ( Site 0419)Recrute dans ce centre
- Guangzhou, ChineSouthern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 0413)Recrute dans ce centre
- Guangzhou, ChineSun Yat-sen University Cancer Center-Internal medicine ( Site 0415)Recrute dans ce centre
- Wuhan, ChineUnion Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0418)Recrute dans ce centre
Au total, dans le monde, 67 des 75 centres listés au registre recrutent ; les 8 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 7 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 37 autres lieux
Autres identifiants
- MK-1084-001 · autre identifiant
- jRCT2041220034 · autre registre
- 2022-501563-40-00 · autre registre
- U1111-1281-2482 · autre registre
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.