Cancer, HLA-A*02:01-positive, PRAME Positive
Conditions
Keywords
PRAME
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.
Interventions
DRUGIMC-P115C
IV infusion
Sponsors
Immunocore Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will include sequential assignment for non-randomized and randomized arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Australia, France, Italy, Spain
Contacts
CONTACTImmunocore Medical Information Global
CONTACTImmunocore Medical Information EU
Outcome results
None listed