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NCT Number: NCT07209111

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.

The goals of this study are to learn:

* How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

Recruiting

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Key information

Conditions

Neoplasm Malignant Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital-Medical Oncology ( Site 1003), Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
  • Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
  • Has active infection, other than those permitted per protocol, requiring systemic therapy
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Treatment and study plan

Calderasib

Drug

Oral administration

Other names: MK-1084

Cetuximab

Biological

Intravenous administration

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 76 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 76 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

  3. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 76 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to approximately 76 months

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

  2. Duration of Response (DOR)

    Time frame: Up to approximately 76 months

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

  3. Overall Survival (OS)

    Time frame: Up to approximately 76 months

    OS is defined as the time from randomization to the date of death due to any cause. OS will be presented.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

Acronym: KANDLELIT-014

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Oct 6, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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