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)
Summary
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.
Arms & interventions
- DrugCalderasib
Oral administration
- BiologicalCetuximab
Intravenous administration
Outcome measures
Primary
Objective Response Rate (ORR)
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.
Time frame: Up to approximately 76 months
Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Time frame: Up to approximately 76 months
Number of Participants Who Discontinue Study Treatment Due to an AE
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.
Time frame: Up to approximately 76 months
Secondary
Progression-free Survival (PFS)
Time frame: Up to approximately 76 months
Duration of Response (DOR)
Time frame: Up to approximately 76 months
Overall Survival (OS)
Time frame: Up to approximately 76 months
Eligibility criteria
Study locations (6)
Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland, 21204
START Midwest ( Site 1103)
Grand Rapids, Michigan, 49546
Comprehensive Cancer Centers of Nevada ( Site 1109)
Las Vegas, Nevada, 89169
Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey, 08903
START Mountain Region ( Site 1106)
West Valley City, Utah, 84119
Virginia Cancer Specialists ( Site 1102)
Fairfax, Virginia, 22031