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Recruiting NCT07156136

Study of IMC-P115C in Advanced PRAME-Positive Cancers

Phase I Interventional PRAME Positive Cancer HLA-A*02:01-positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMC-P115C.
Who it may be relevant to
Registry conditions: PRAME Positive, Cancer, HLA-A*02:01-positive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, France, Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A 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 Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers

Overview

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

  • Drug IMC-P115C
    IV infusion

Primary outcome measures

  • Percentage of participants with dose-limiting toxicities (DLT) [Time frame: Up to ~16 months]
  • Percentage of participants with adverse events (AE) [Time frame: Up to ~16 months]
  • Percentage of participants with serious adverse events (SAE) [Time frame: Up to ~16 months]
  • Percentage of participants with a dose interruption, reduction, or discontinuation [Time frame: Up to ~16 months]
Secondary outcome measures (8)
  • Best Overall Response (BOR) as determined by RECIST v1.1 per the Investigator. [Time frame: Up to ~19 months]
  • Duration of Response (DOR) as determined by RECIST v1.1 per the Investigator. [Time frame: Up to ~19 months]
  • Progression Free Survival (PFS) as determined by RECIST v1.1 per the Investigator. [Time frame: Up to ~19 months]
  • Overall Survival (OS) [Time frame: Up to ~19 months]
  • Change from baseline in lymphocyte counts [Time frame: Up to ~19 months]
  • Changes in serum cytokine concentrations [Time frame: Up to ~19 months]
  • IMC-P115C Plasma Concentration [Time frame: Up to ~19 months]
  • Percentage of participants with anti-IMC-P115C antibody formation [Time frame: Up to ~19 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 4 centers
  • Hospital Universitari Vall d Hebron — Barcelona
  • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals — Barcelona
  • Hospital Universitario Ramon y Cajal — Madrid
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid
Australia · 3 centers
  • Cancer Research South Australia (CRSA) — Adelaide
  • Linear Clinical Research ltd. — Nedlands
  • Melanoma Institute Australia — Wollstonecraft
France · 3 centers
  • UNICANCER - Centre Leon-Berard (CLB) — Lyon
  • Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Tou — Toulouse
  • Institut Gustave Roussy — Villejuif
Italy · 3 centers
  • Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan
  • Istituto Europeo di Oncologia — Milan
  • Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale" — Naples

Identifiers

NCT: NCT07156136 · IMC-P115C-1005 · 2023-509767-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗