Your session is about to expire
← Back to Search
Monoclonal Antibodies
FMC-376 for Colorectal Cancer (PROSPER Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Frontier Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
PROSPER Trial Summary
This trial will test a drug called FMC-376 in patients with advanced solid tumors that have a specific genetic mutation. The trial will have three parts to determine the safety and effectiveness of the drug at
Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change called KRAS G12C mutation. They should have tried standard treatments without success or can't tolerate them, and their blood, kidney, and liver functions must be stable. Participants need to be fairly active and well (ECOG status 0 or 1) and agree not to join other drug studies.Check my eligibility
What is being tested?
FMC-376 is being tested in people with certain types of cancer like colorectal, lung, and pancreatic cancers. The study has three parts: finding the right dose (Phase 1A), confirming this dose in more patients (Phase 1B), and then testing it in specific groups of patients (Phase 2).See study design
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions at the injection site, fatigue, nausea, changes in blood counts affecting immunity or clotting risk, liver or kidney function changes.
PROSPER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My cancer is advanced, cannot be surgically removed, and has a KRAS G12C mutation.
PROSPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Dose Limiting Toxicities
Secondary outcome measures
Area Under Blood Concentration-Time Curve (AUC) of FMC-376
Clearance (CL) of FMC-376 from Blood Plasma
Disease Control Rate (DCR)
+9 morePROSPER Trial Design
1Treatment groups
Experimental Treatment
Group I: FMC-376Experimental Treatment1 Intervention
Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
Find a Location
Who is running the clinical trial?
Frontier Medicines CorporationLead Sponsor
Andrew Krivoshik, MD, PhDStudy DirectorFrontier Medicines Corporation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for potential participants to enroll in this clinical trial?
"As per clinicaltrials.gov, this current medical investigation is in the process of enrolling volunteers. The trial was initially listed on 2/1/2024 and had its latest update on 2/7/2024."
Answered by AI
What is the uppermost limit for participant enrollment in this research endeavor?
"Indeed, information on clinicaltrials.gov confirms the ongoing recruitment of participants for this study. Originally listed on February 1st, 2024, and most recently revised on February 7th, 2024, the trial aims to enroll a total of 403 individuals from two designated locations."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger