Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509767-25 | Other Identifier | EU CTR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: IMC-P115C Monotherapy | Experimental | Participants receive IMC-P115C intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-P115C | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Percentage of participants with dosing changes or discontinuations. | Up to ~16 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Immunocore Medical Information Global | Contact | 844-466-8661 | medical.information@immunocore.com | |
| Immunocore Medical Information EU | Contact | +00 800-744-51111 | medinfo.eu@immunocore.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research South Australia (CRSA) | Recruiting | Adelaide | 5000 | Australia | ||
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
The study will include sequential assignment for non-randomized and randomized arms.
Not provided
Not provided
Not provided
Not provided
| Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator. |
| Up to ~19 months |
| Overall Survival (OS) | OS is the time from first dose of study therapy until death due to any cause. | Up to ~19 months |
| Change from baseline in lymphocyte counts | Change from baseline in lymphocyte counts | Up to ~19 months |
| Changes in serum cytokine concentrations | Change from baseline in serum cytokine concentrations | Up to ~19 months |
| IMC-P115C Plasma Concentration | IMC-P115C plasma concentration | Up to ~19 months |
| Percentage of participants with anti-IMC-P115C antibody formation | Up to ~19 months |
| Linear Clinical Research ltd. |
| Recruiting |
| Nedlands |
| 06009 |
| Australia |
| Melanoma Institute Australia | Recruiting | Wollstonecraft | 2065 | Australia |
| UNICANCER - Centre Leon-Berard (CLB) | Recruiting | Lyon | 69008 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) | Recruiting | Toulouse | 31059 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" | Recruiting | Naples | 80131 | Italy |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | 08035 | Spain |
| Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals | Recruiting | Barcelona | 08908 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| START Madrid - Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |