Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
- Interventional
- Recruiting
- NCT03973333
Contact Information
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
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.
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 MTD and/or expansion dose of IMC-C103C as a single agent administered IV and SC Q1W and administered Q1W in combination with 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.
1. To identify the MTD and/or expansion dose of IMC-C103C as a single agent administered IV and SC Q1W and administered Q1W in combination with 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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
1. HLA-A*02:01 positive
2. MAGE-A4 positive tumor
3. 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
Exclusion Criteria:
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
1. HLA-A*02:01 positive
2. MAGE-A4 positive tumor
3. 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
Exclusion Criteria:
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