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New treatment option for PRAME Positive
Official title Study of IMC-P115C in Advanced PRAME-Positive Cancers
ClinicalTrials.gov ID: NCT07156136
What this study is testing
What is IMC-P115C?
IMC-P115C is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prame positive.
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
- Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
- Phase 1: an early, usually small safety study
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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- HLA-A\ 02:01-positive
- Meeting PRAME-positive tumor testing requirements
- Metastatic or unresectable solid tumors
- Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
You likely can't join if
- Symptomatic or untreated central nervous system metastasis
- Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
- Ongoing ascites or effusion requiring recent drainages
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant lung, heart, or autoimmune disease
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- HLA-A\ 02:01-positive
- Meeting PRAME-positive tumor testing requirements
- Metastatic or unresectable solid tumors
- Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control
- Symptomatic or untreated central nervous system metastasis
- Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment
- Ongoing ascites or effusion requiring recent drainages
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant lung, heart, or autoimmune disease
- Ongoing requirement for immunosuppressive treatment
- Significant secondary malignancy
- Hypersensitivity to study drug or excipients
- Pregnant or lactating
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, Australia
- Nedlands, Australia
- Wollstonecraft, Australia
- Lyon, France
- Toulouse, France
- Villejuif, France
- Milan, Italy
- Naples, Italy
- Barcelona, Spain
- Madrid, Spain
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 - 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?
Study sites include Adelaide, Australia; Nedlands, Australia; Wollstonecraft, Australia; Lyon, France; Toulouse, France; Villejuif, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.