Safety and Effectiveness of Experimental IMC-C103C With or Without Atezolizumab for Advanced MAGE-A4-positive Cancer

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Select Advanced Solid Tumors, ImmTAC, IMC-C103C, MAGE-A4, immunotherapy, Atezolizumab, IMC-C103C, IMC-C103C - expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  1. HLA-A*02:01 positive
  2. MAGE-A4 positive tumor
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1
  4. Selected advanced solid tumors
  5. Relapsed from, refractory to, or intolerant of standard therapy
  6. Measurable disease per RECIST v1.1 (expansion)
  7. If applicable, must agree to use highly effective contraception

You CAN'T join if...

  1. Symptomatic or untreated central nervous system metastasis
  2. Inadequate washout from prior anticancer therapy
  3. Significant ongoing toxicity from prior anticancer treatment
  4. Impaired baseline organ function as evaluated by out-of-range laboratory values
  5. Clinically significant cardiac disease
  6. Active infection requiring systemic antibiotic therapy
  7. Known history of human immunodeficiency virus (HIV)
  8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
  10. Significant secondary malignancy
  11. Pregnancy or lactation

Locations

  • University of California Davis Comprehenvise Cancer Center
    Sacramento California 95817 United States
  • The Angeles Clinic and Research Institute
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunocore Ltd
Links
Sign up for this study
ID
NCT03973333
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Last Updated