Advanced Solid Tumors With KRAS G12C Mutations study: FMC-376
Official title A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
ClinicalTrials.gov ID: NCT06244771
What this study is testing
What is FMC-376?
an investigational oral capsule being studied as a potential treatment for advanced solid tumors with KRAS G12C mutations
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of FMC-376 and see if it helps shrink tumors in people with advanced solid tumors that have a KRAS G12C mutation.
- Who it's for
- The study is looking for adults with advanced solid tumors, such as lung, colorectal, or pancreatic cancer, that cannot be removed by surgery and have a KRAS G12C mutation.
- What's involved
- Participants will receive FMC-376 and undergo regular medical tests and check-ups to monitor how their body reacts to the drug and how the tumor responds.
- Time commitment
- The study has three parts, starting with dose testing and moving to larger groups, but the specific total duration and visit schedule are not listed in the provided text.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, and hepatic function
You likely can't join if
- 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
- For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of...
See the full eligibility 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
- NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, and hepatic function
- Agrees not to participate in another treatment study while receiving study drug
- For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis
- 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
- For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- San Francisco, California, United States
- Dyer, Indiana, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Macquarie Park, New South Wales, Australia
- Southport, Queensland, Australia
- Kurralta Park, South Australia, Australia
- Nedlands, Western Australia, Australia
- Seoul, Jongno-gu, South Korea
- Seoul, Seodaemun-gu, South Korea
- Seoul, Seongbuk-gu, South Korea
- Gyeonggi-do, Seongnam-si, South Korea
- Gyeonggi-do, Suwon-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; San Francisco, California, United States; Dyer, Indiana, United States; Fairway, Kansas, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.