Informations générales (source: ClinicalTrials.gov)
Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Interventional
Phase 1/Phase 2
Immunocore Ltd (Voir sur ClinicalTrials)
février 2020
août 2026
29 octobre 2024
Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer
(ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated
antigen PRAME. This is a first-in-human trial designed to evaluate the safety and
efficacy of brenetafusp in adult patients who have the appropriate HLA-A2 tissue marker
and whose cancer is positive for PRAME.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:13 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 17/05/2024 12:55:13 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Saint-Louis - Centre d'Onco-Dermatologie - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Nouvelle-Aquitaine - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Universite Claude Bernard Lyon Est - 69100 - Lyon - Villeurbanne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. ECOG PS 0 or 1
2. HLA-A*02:01 positive
3. PRAME positive tumor
4. Relapsed from, refractory to, or intolerant of standard therapies; or, in
combination with standard therapies
5. If applicable, must agree to use highly effective contraception
1. ECOG PS 0 or 1
2. HLA-A*02:01 positive
3. PRAME positive tumor
4. Relapsed from, refractory to, or intolerant of standard therapies; or, in
combination with standard therapies
5. If applicable, must agree to use highly effective contraception
1. Symptomatic or untreated central nervous system metastasis
2. Recent bowel obstruction
3. Ongoing ascites or effusion requiring recent drainages
4. Significant immune-mediated adverse event with prior immunotherapy (patients in
checkpoint inhibitor combination treatment)
5. Inadequate washout from prior anticancer therapy
6. Significant ongoing toxicity from prior anticancer treatment
7. Out-of-range laboratory values
8. Clinically significant lung, heart, or autoimmune disease
9. Ongoing requirement for immunosuppressive treatment
10. Prior solid organ or bone marrow transplant
11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency
virus (HIV) infection
12. Significant secondary malignancy
13. Hypersensitivity to study drug or excipients
14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study
intervention
15. Pregnant or lactating
16. Any other contraindication for applicable combination partner based on local
prescribing information