Clinical Trial 22685
- Cancer Type: Multiple
- Study Type: Treatment
- NCT#: NCT06040541
- Phase: Phase I
- Principal Investigator: Kim, Dae Won
- 813-745-6100
- Or 1-800-679-0775
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Overview
Study Title:
Phase 1/1B, Multicenter, Open-Label, Study of RMC-9805 in Participants with Advanced KRASG12D-Mutant Solid Tumors
Summary:
This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.
Objective:
Primary Objectives * To evaluate the safety and tolerability of RMC-9805 monotherapy in adults with KRASG12D-mutant solid tumors. * To estimate the MTD and/or RP2DS for RMC-9805 monotherapy in adults with KRASG12D-mutant solid tumors. Secondary Objectives * To characterize the blood PK of RMC-9805 after single- and repeat-dose administration. * To evaluate preliminary anti-tumor effects of RMC-9805 monotherapy in KRASG12D-mutant solid tumors. * To evaluate the effect of food on the PK of RMC-9805 monotherapy.
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Treatments
Therapies:
Therapy (NOS)
Medications:
RMC-9805 ()
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Inclusion Criteria
- Inclusion Criteria:
- Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test
- Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Other criteria may apply
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Exclusion Criteria
- Exclusion Criteria:
- Primary central nervous system (CNS) tumors
- Known or suspected leptomeningeal or active brain metastases or spinal cord compression
- Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
- Participant was previously treated with an investigational KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
- Other criteria may apply
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