Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
Immunocore Ltd (Voir sur ClinicalTrials)
novembre 2024
août 2029
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Kaissa OUALI | 24/04/2026 09:05:05 | Contacter | ||
Critères
Tous
- 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