Health Trials

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Calderasib
  • Pembrolizumab
  • carboplatin
  • pemetrexed
  • cetuximab
  • oxaliplatin
  • leucovorin
  • 5-fluorouracil

Treatment groups

830 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

75
Argentina
Instituto Alexander Fleming ( Site 0434)C1426ANZ, Ciudad Autónoma de Buenos AiresBuenos Aires, Argentina
Sanatorio Parque ( Site 0456)S2000DSV, RosarioSanta Fe Province, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0438)F5300COE, La Rioja Argentina
Australia
Chris O'Brien Lifehouse ( Site 0002)2050, CamperdownNew South Wales, Australia

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Source ClinicalTrials.gov