NCT03973333

Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Immunocore Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

Detailed description

The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab. 2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.

Conditions

• Select Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	IMC-C103C	Weekly IV infusions
DRUG	Atezolizumab	IV infusions every 3 weeks
DRUG	IMC-C103C	Weekly subcutaneous Injection

Timeline

• Start date: 2019-05-17
• Primary completion: 2023-09-25
• Completion: 2023-09-25
• First posted: 2019-06-04
• Last updated: 2024-10-18

Locations

19 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study