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
Sex
ALL
Min age
18 Years
Max age
—
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
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
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.
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