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.
Primary Objectives:
- To evaluate ORR for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR.
- To compare MK-1084 plus cetuximab versus MK-1084 with respect to ORR per RECIST 1.1 as assessed by BICR.
Secondary Objectives:
- To evaluate OS for MK-1084 and MK-1084 plus cetuximab
- To evaluate DOR for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR
- To evaluate PFS for MK-1084 and MK-1084 plus cetuximab per RECIST 1.1 as assessed by BICR.
Chemotherapy single agent systemic
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.