Clinical Trials in Italy / NCT07156136
Recruiting
Phase 1
Study of IMC-P115C in Advanced PRAME-Positive Cancers
NCT07156136 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
PRAME PositiveCancerHLA-A*02:01-positive
Investigational drug(s) / intervention(s)
IMC-P115C
IMC-P115C: IV infusion
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Research South Australia (CRSA) | Adelaide | Australia | Recruiting |
| Linear Clinical Research ltd. | Nedlands | Australia | Recruiting |
| Melanoma Institute Australia | Wollstonecraft | Australia | Recruiting |
| UNICANCER - Centre Leon-Berard (CLB) | Lyon | France | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) | Toulouse | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia | Milan | Italy | Recruiting |
| Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" | Naples | Italy | Recruiting |
| Hospital Universitari Vall d Hebron | Barcelona | Spain | Recruiting |
| Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals | Barcelona | Spain | Recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Recruiting |
| START Madrid - Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07156136 on ClinicalTrials.gov ↗ ← All trials in Italy