Study of IMC-P115C in Advanced PRAME-Positive Cancers
- Conditions
- PRAME PositiveCancerHLA-A*02:01-positive
- Interventions
- Registration Number
- NCT07156136
- Lead Sponsor
- Immunocore Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm A: IMC-P115C Monotherapy IMC-P115C Participants receive IMC-P115C intravenous (IV) infusion
- Primary Outcome Measures
Name Time Method Percentage of participants with dose-limiting toxicities (DLT) Up to ~16 months Percentage of participants with adverse events (AE) Up to ~16 months Percentage of participants with serious adverse events (SAE) Up to ~16 months Percentage of participants with a dose interruption, reduction, or discontinuation Up to ~16 months Percentage of participants with dosing changes or discontinuations.
- Secondary Outcome Measures
Name Time Method Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator. Up to ~19 months Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator. Up to ~19 months Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator. Up to ~19 months Overall Survival (OS) Up to ~19 months OS is the time from first dose of study therapy until death due to any cause.
Change from baseline in lymphocyte counts Up to ~19 months Change from baseline in lymphocyte counts
Changes in serum cytokine concentrations Up to ~19 months Change from baseline in serum cytokine concentrations
IMC-P115C Plasma Concentration Up to ~19 months IMC-P115C plasma concentration
Percentage of participants with anti-IMC-P115C antibody formation Up to ~19 months
Trial Locations
- Locations (13)
Cancer Research South Australia (CRSA)
🇦🇺Adelaide, Australia
Linear Clinical Research ltd.
🇦🇺Nedlands, Australia
Melanoma Institute Australia
🇦🇺Wollstonecraft, Australia
UNICANCER - Centre Leon-Berard (CLB)
🇫🇷Lyon, France
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Fondazione IRCCS - Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"
🇮🇹Napoli, Italy
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Spain
Scroll for more (3 remaining)Cancer Research South Australia (CRSA)🇦🇺Adelaide, Australia