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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05067283
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calderasib — DRUG
    Oral dose
  • Pembrolizumab — BIOLOGICAL
    Intravenous infusion of 200 mg
  • carboplatin — DRUG
    Per label
  • pemetrexed — DRUG
    Per label
  • cetuximab — BIOLOGICAL
    Per label
  • oxaliplatin — DRUG
    Per label
  • leucovorin — DRUG
    Per label
  • 5-fluorouracil — DRUG
    Per label

Study Details

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.

Key Dates

Start date
Dec 17, 2021
Status verified
May 2026
Primary completion
Feb 25, 2030
Completion
Feb 25, 2030

Study Design

Enrollment
830 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive daily oral escalating doses of up to 800 mg of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
  • Experimental: Arm 2
    Participants will receive calderasib daily oral escalating dose of up to 800 mg plus pembrolizumab given as a 200 mg intravenous infusion once every 21-day cycle up to a total of 35 cycles (up to \~24 months). Treatment with calderasib will continue until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
  • Experimental: Arm 3
    Participants will receive alternate formulation of calderasib until progressive disease or discontinuation. Dosing regimen may be adjusted based on safety.
  • Experimental: Arm 4
    Participants will receive calderasib daily oral dose plus an intravenous infusion of pembrolizumab (200 mg) once every 21-day cycle for up to 35 cycles (up to \~24 months). Participants will also receive carboplatin (per label) and pemetrexed (per label) once every 21-day cycle for the first 4 cycles.
  • Experimental: Arm 5
    Participants will receive calderasib daily oral dose plus an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle.
  • Experimental: Arm 6
    Participants will receive calderasib daily oral dose. Additionally, participants receive an intravenous infusion of cetuximab (per label) every 2 weeks of each 28-day cycle, oxaliplatin (per label) for first 6 cycles, and leucovorin (per label) and 5-fluorouracil (per label) once every 14-days.

Primary Outcome Measure

Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) [ Time Frame: Up to ~21 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Moffitt Cancer Center ( Site 0261)TampaFlorida33612
Study Coordinator
813-745-5995
START Midwest ( Site 0267)Grand RapidsMichigan49546
Study Coordinator
616-954-5554
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)HackensackNew Jersey07601
Study Coordinator
551-996-5900
Laura and Isaac Perlmutter Cancer Center ( Site 0270)New YorkNew York10016-
NEXT Virginia ( Site 0271)FairfaxVirginia22031
Study Coordinator
703-280-5390
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)MilwaukeeWisconsin53226
Study Coordinator
414-805-0505

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLSTART Midwest· Grand Rapids, MIJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJLaura and Isaac Perlmutter Cancer Center· New York, NYNEXT Virginia· Fairfax, VAMEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office· Milwaukee, WI

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