Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors (NCT04262466) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
United States, Australia, Austria410 participantsStarted 2020-02-25
Plain-language summary
Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult participants who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ECOG PS 0 or 1
. HLA-A\*02:01 positive
. PRAME positive tumor
. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies
. If applicable, must agree to use highly effective contraception
Exclusion criteria
. Symptomatic or untreated central nervous system metastasis
. Recent bowel obstruction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Incidence of dose-limiting toxicity (DLT)s
Timeframe: Up to ~28 days after each dose
2
Phase 1: Incidence of adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to 30 days after the last dose of study therapy
3
Phase 1: Number of participants with dose interruptions, dose reductions, or dose discontinuations
Timeframe: Up to ~12 months
4
Phase 1: Number of participants with abnormal laboratory test results (hematology)
Timeframe: Up to 30 days after the last dose of study therapy
5
Phase 1: Number of participants with abnormal laboratory test results (chemistry)
Timeframe: Up to 30 days after the last dose of study therapy
6
Phase 1: Number of participants with abnormal laboratory test results (coagulation)
Timeframe: Up to 30 days after the last dose of study therapy
7
Phase 1: Number of participants with abnormal urinalysis