Advanced Solid Tumors Clinical Trial
Official title:
Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors
This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.
Status | Recruiting |
Enrollment | 290 |
Est. completion date | July 31, 2026 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - ECOG performance status 0 or 1 - Adequate organ function 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 inclusion/exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Mary Crowley Cancer Research | Dallas | Texas |
United States | NEXT Oncology Virginia | Fairfax | Virginia |
United States | University of Texas, MD Anderson Cancer Center | Houston | Texas |
United States | Carolina BioOncology Institute | Huntersville | North Carolina |
United States | START | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Revolution Medicines, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs | Up to 3 years | |
Primary | Dose Limiting Toxicities | Number of participants with Dose Limiting Toxicities (DLTs) | 21 days | |
Secondary | Maximum Observed Blood Concentration (Cmax) of RMC-9805 | Cmax | up to 21 weeks | |
Secondary | Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 | Tmax | up to 21 weeks | |
Secondary | Area Under Blood Concentration Time Curve (AUC) of RMC-9805 | AUC | up to 21 weeks | |
Secondary | Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing | accumulation ratio of RMC-9805 | up to 21 weeks | |
Secondary | Elimination Half-Life (t1/2) of RMC-9805 | t1/2 | up to 21 weeks | |
Secondary | Overall Response Rate (ORR) | Assess per RECIST v1.1 | up to 3 years | |
Secondary | Duration of Response (DOR) | Assess per RECIST v1.1 | up to 3 years | |
Secondary | Disease Control Rate (DCR) | Assess per RECIST v1.1 | up to 3 years | |
Secondary | Time to Response (TTR) | Assess per RECIST v1.1 | up to 3 years | |
Secondary | Progression-Free Survival (PFS) | Assess per RECIST v1.1 | up to 3 years |
Status | Clinical Trial | Phase | |
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