Advanced Solid Tumors With KRAS G12C Mutations, Colorectal Cancer, KRAS G12C, Metastatic Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Cancer, Solid Tumor, Adult, Unresectable Solid Tumor
Conditions
Keywords
Lung Cancer, KRAS, G12C
Brief summary
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
Interventions
DRUGFMC-376
Oral Capsule Daily
Sponsors
Frontier Medicines Corporation
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1A: sequential; Phase 1B and Phase 2: parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation * Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hematological, renal, and hepatic function * Agrees not to participate in another interventional study while receiving study drug
Exclusion criteria
* Leptomeningeal disease or carcinomatous meningitis * Clinically significant toxicity resulting from prior cancer therapies * Known or suspected hypersensitivity to FMC-376 or any components of the study drug * Condition that would interfere with study drug absorption * Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities | Up to 21 Days | Number of participants with Dose Limiting Toxicities (DLTs) |
| Adverse Events (AEs) | Approximately 24 Months | Number of participants with treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of FMC-376 | Approximately 24 Months | Cmax |
| Time to Reach Maximum Blood Concentration (Tmax) of FMC-376 | Approximately 24 Months | Tmax |
| Minimum Observed Plasma Concentration (Cmin) of FMC-376 | Approximately 24 Months | Cmin |
| Elimination Half-life (t1/2) of FMC-376 | Approximately 24 Months | t1/2 |
| Area Under Blood Concentration-Time Curve (AUC) of FMC-376 | Approximately 24 Months | AUC |
| Volume of Distribution (Vd) of FMC-376 | Approximately 24 Months | Vd |
| Clearance (CL) of FMC-376 from Blood Plasma | Approximately 24 Months | CL |
| Overall Response Rate (ORR) | Approximately 24 Months | Assess per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Duration of Response (DOR) | Approximately 24 Months | Assess per RECIST v1.1 |
| Disease Control Rate (DCR) | Approximately 24 Months | Assess per RECIST v1.1 |
| Progression-Free Survival (PFS) | Approximately 24 Months | Assess per RECIST v1.1 |
| Overall Survival (OS) | Approximately 24 Months | — |
Countries
Australia, South Korea, United States
Contacts
CONTACTMedical Lead
STUDY_DIRECTORMedical Lead
Frontier Medicines Corporation
Outcome results
None listed