Back to search results

Study of Calderasib for Advanced Solid Tumors with KRAS G12C Mutation

This study is looking at the safety and effectiveness of a drug called calderasib, both by itself and when given with other treatments like pembrolizumab, carboplatin, pemetrexed, or cetuximab. It's for people with advanced solid tumors that have a specific genetic change called a KRAS G12C mutation. Researchers will be watching for any side effects and how well the treatments work. To join, you must be at least 18 years old, have measurable disease, and good organ function. The study aims to enroll about 830 participants. The main goals are to track side effects and how many people stop treatment due to side effects over time.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll about 830 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 56 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05067283

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~830 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:CalderasibPembrolizumabcarboplatinpemetrexedcetuximaboxaliplatin

At a glance

Recruiting sites
67 of 75 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Measured over Up to ~21 days
+2 more outcomes measured

Conditions

Advanced Solid Tumors

Explore related trials

Colorectal AdenocarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

75 sites across 56 states
Israel5
New South Wales3
Ontario3
Region M. de Santiago3
Guangdong2
Shanghai Municipality2
Tokyo2
Panama2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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
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

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
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

What this trial measures

  • 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 AEUp 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.