Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers

Phase 1

Recruiting

• Conditions: Advanced PRAME-Positive Cancers; MedDRA version: 20.0Level: LLTClassification code: 10046769Term: Uterine carcinoma Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10033131Term: Ovarian carcinoma Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10042863Term: Synovial sarcoma Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10025665Term: Malignant melanoma of skin stage unspecified Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502684-37-00
• Lead Sponsor: Immunocore Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

Participant must be = 18 years of age, inclusive, at the time of signing the ICF, Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 at start of treatment, HLA-A*02:01-positive, Must meet tumor PRAME testing requirements, Relapsed from, refractory to, or intolerant of standard therapies; or in combination with standard therapies

Exclusion Criteria

Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all the following apply: a. Treated CNS lesions must be radiographically stable for = 2 weeks after intervention (surgery and/or radiation). b. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to enrollment., Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment, Ongoing ascites or effusion requiring drainage within 28 days prior to the planned first dose of study treatment., Presence of NCI CTCAE = Grade 2 toxicity due to prior cancer therapy, Participants enrolling in pembrolizumab combination arms with prior immunotherapy exposure must not have experienced immune-mediated AE (imAE)/immune-related AE (irAE), Clinically significant pulmonary disease or impaired lung function, Clinically significant cardiac disease or impaired cardiac function, Participants with elevated risk of thrombotic/thromboembolic event

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified