Description:
IMC-C103C is an immune mobilizing 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.
Title
- Brief Title: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
- 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
Clinical Trial IDs
- ORG STUDY ID:
IMC-C103C-101
- NCT ID:
NCT03973333
Conditions
- Select Advanced Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| IMC-C103C | | IMC-C103C - Arm A1 |
| Atezolizumab | TECENTRIQ | IMC-C103C and atezolizumab Arm A2 |
Purpose
IMC-C103C is an immune mobilizing 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 MTD and/or RP2D of IMC-C103C as a single agent administered Q1W (Arm A1)
and administered Q1W in combination with Q3W atezolizumab (Arm A2).
2. To assess the preliminary anti-tumor activity of IMC C103C in one or more selected
indications, as a single agent administered Q1W (Arm B1) and administered Q1W in
combination with Q3W atezolizumab (Arm B2).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| IMC-C103C - Arm A1 | Experimental | n= approximately 28 patients to establish the MTD/RP2D | |
| IMC-C103C and atezolizumab Arm A2 | Experimental | n=approximately 12 patients to establish the MTD/RP2D | |
| IMC-C103C - Arm B1 | Experimental | Patients will be enrolled n=9-24 metastatic/unresectable tumors of interest patients treated at the RP2D of IMC-C103C to assess preliminary anti-tumor efficacy | |
| IMC-C103C and atezolizumab Arm B2 | Experimental | Patients will be enrolled n=9-24 metastatic/unresectable tumors of interest patients treated at the RP2D of IMC-C103C to assess preliminary anti-tumor efficacy | |
Eligibility Criteria
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
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase 1: Incidence of dose-limiting toxicities (DLT) |
| Time Frame: | From first dose to DLT period (21 days) |
| Safety Issue: | |
| Description: | Abnormalities will be classified according to NCI CTCAE v5.0 |
Secondary Outcome Measures
| Measure: | Phase 2: incidence and severity of adverse events (AE) |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | |
| Measure: | Phase 2: changes in laboratory parameters |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Abnormalities will be classified according to NCI CTCAE v5.0 |
| Measure: | Phase 2: changes in vital signs |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | Abnormalities will be classified according to NCI CTCAE v5.0 |
| Measure: | Phase 2: changes in electrocardiogram parameters |
| Time Frame: | from first dose to 30 days after the last dose |
| Safety Issue: | |
| Description: | QTcF interval absolute values and changes from baseline will be summarized |
| Measure: | Phase 2: dose interruptions, reductions, and discontinuations |
| Time Frame: | from first dose through last dose (anticipated for up to 12 months) |
| Safety Issue: | |
| Description: | |
| Measure: | Phase 1: Best overall response |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics Area under the plasma concentration-time curve (AUC) |
| Time Frame: | from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax) |
| Time Frame: | from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The time to reach maximum plasma concentration (Tmax) |
| Time Frame: | from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The elimination half-life (t1/2) |
| Time Frame: | from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Immunogenicity the incidence of anti-drug antibody formation |
| Time Frame: | from first dose to 14 days after the last dose |
| Safety Issue: | |
| Description: | |
| Measure: | Changes in lymphocyte counts over time |
| Time Frame: | from first dose to 30 days after last dose" given CBC with diff is collected throughout until 30 after last dose |
| Safety Issue: | |
| Description: | |
| Measure: | Changes in serum cytokines over time |
| Time Frame: | from first dose to approx.. 6wks |
| Safety Issue: | |
| Description: | Cytokine / chemokine concentration data will be listed, summarized, or analyzed by treatment group for Phase 1 and separately for each Phase 2 cohort. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Immunocore Ltd |
Trial Keywords
- ImmTAC, IMC-C103C, MAGE-A4, immunotherapy
Last Updated
March 24, 2021
