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Monoclonal Antibodies

FMC-376 for Solid Tumors (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
Must not have
Leptomeningeal disease or carcinomatous meningitis
Condition that would interfere with study drug absorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is advanced, cannot be surgically removed, and has a KRAS G12C mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the lining of my brain or spinal cord.
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I do not have any conditions that affect how my body absorbs medication.
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I have severe side effects from previous cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events (AEs)
Dose Limiting Toxicities
Secondary study objectives
Area Under Blood Concentration-Time Curve (AUC) of FMC-376
Clearance (CL) of FMC-376 from Blood Plasma
Disease Control Rate (DCR)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~269 spots leftby Oct 2027
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