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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMC-376 | Experimental | Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMC-376 | Drug | Oral Capsule Daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Number of participants with Dose Limiting Toxicities (DLTs) | Up to 21 Days |
| Adverse Events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs) | Approximately 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of FMC-376 | Cmax | Approximately 24 Months |
| Time to Reach Maximum Blood Concentration (Tmax) of FMC-376 | Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Lead | Contact | +1 (650) 457-1005 | clinicaltrials@frontiermeds.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Lead | Frontier Medicines Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center | Recruiting | La Jolla | California | 92037 | United States |
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Phase 1A: sequential; Phase 1B and Phase 2: parallel
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| Approximately 24 Months |
| Minimum Observed Plasma Concentration (Cmin) of FMC-376 | Cmin | Approximately 24 Months |
| Elimination Half-life (t1/2) of FMC-376 | t1/2 | Approximately 24 Months |
| Area Under Blood Concentration-Time Curve (AUC) of FMC-376 | AUC | Approximately 24 Months |
| Volume of Distribution (Vd) of FMC-376 | Vd | Approximately 24 Months |
| Clearance (CL) of FMC-376 from Blood Plasma | CL | Approximately 24 Months |
| Overall Response Rate (ORR) | Assess per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Approximately 24 Months |
| Duration of Response (DOR) | Assess per RECIST v1.1 | Approximately 24 Months |
| Disease Control Rate (DCR) | Assess per RECIST v1.1 | Approximately 24 Months |
| Progression-Free Survival (PFS) | Assess per RECIST v1.1 | Approximately 24 Months |
| Overall Survival (OS) | Approximately 24 Months |
| University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center | Completed | Orange | California | 92868 | United States |
| University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | Recruiting | San Francisco | California | 94158 | United States |
|
| Florida Cancer Specialists and Research Institute | Completed | Lake Mary | Florida | 32746 | United States |
| Northwest Cancer Centers | Recruiting | Dyer | Indiana | 46311 | United States |
|
| The University of Kansas Cancer Center | Recruiting | Fairway | Kansas | 66205 | United States |
|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Community Clinical Trials | Completed | Kingwood | Texas | 77339 | United States |
| South Texas Accelerated Research Therapeutics, LLC | Recruiting | San Antonio | Texas | 78229 | United States |
|
| UT Health San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
|
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Macquarie University | Recruiting | Macquarie Park | New South Wales | 2109 | Australia |
|
| Tasman Health Care | Recruiting | Southport | Queensland | 4215 | Australia |
|
| Icon Cancer Centre Kurralta Park | Recruiting | Kurralta Park | South Australia | 5037 | Australia |
|
| GenesisCare North Adelaide | Recruiting | North Adelaide | South Australia | 5006 | Australia |
|
| Eastern Health - Box Hill Hospital | Recruiting | Box Hill | Victoria | 3128 | Australia |
|
| Linear Clinical Research Ltd | Recruiting | Nedlands | Western Australia | 6009 | Australia |
|
| Seoul National University Hospital | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | Seodaemun-gu | 03722 | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | Seongbuk-gu | 02841 | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | Seongnam-si | 13620 | South Korea |
|
| The Catholic University of Korea, St. Vincent's Hospital | Recruiting | Gyeonggi-do | Suwon-si | 16247 | South Korea |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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