Description:
IMC-F106C is an immune-mobilizing T cell receptor against cancer (ImmTAC ®) designed for the
treatment of cancers positive for the tumor-associated antigen PRAME. This is a
first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult
patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Title
- Brief Title: Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
- Official Title: Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers
Clinical Trial IDs
- ORG STUDY ID:
IMC-F106C-101
- NCT ID:
NCT04262466
Conditions
- Select Advanced Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| IMC-F106C | | IMC-F106C - Arm A - Phase 1 |
| anti-PD(L)1 | | IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1 |
Purpose
IMC-F106C is an immune-mobilizing T cell receptor against cancer (ImmTAC ®) designed for the
treatment of cancers positive for the tumor-associated antigen PRAME. This is a
first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult
patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Detailed Description
The IMC-F106C-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. Phase 1: To identify the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 dose
(RP2D) of IMC-F106C as a single agent (Arm A) and administered in combination with
Checkpoint Inhibitors (Arm B).
2. Phase 2: To assess the preliminary anti-tumor activity of IMC-F106C in up to 4
indications, as a single agent administration.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| IMC-F106C - Arm A - Phase 1 | Experimental | Dose Escalation | |
| IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1 | Experimental | Dose Escalation | |
| IMC-F106C - Phase 2 | Experimental | Monotherapy dose expansion | |
Eligibility Criteria
Inclusion Criteria:
1. ECOG PS 0 or 1
2. HLA-A*02:01 positive
3. PRAME positive tumor
4. Relapsed from, refractory to, or intolerant of standard therapy
5. If applicable, must agree to use highly effective contraception
6. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the Informed Consent (ICF) and protocol
Exclusion Criteria:
1. Symptomatic or untreated central nervous system metastasis
2. Recent bowel obstruction
3. Ascites requiring recurrent paracentesis
4. Significant immune-mediated adverse event with prior immunotherapy (patients in
combination treatment)
5. Inadequate washout from prior anticancer therapy
6. Significant ongoing toxicity from prior anticancer treatment
7. Out-of-range laboratory values
8. Clinically significant medical condition
9. Ongoing requirement for immunosuppressive treatment
10. Prior solid organ or bone marrow transplant
11. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
12. Known history of human immunodeficiency virus (HIV)
13. Significant secondary malignancy
14. Hypersensitivity to study drug or excipients
15. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study
intervention
16. Pregnant or lactating
| 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 toxicity (DLT)s |
| Time Frame: | From first dose to DLT period (28 days) |
| Safety Issue: | |
| Description: | Number of participants with, and rate of, Grade 1, Grade 2, Grade 3, and Grade 4 (as applicable per NCI CTCAE v5.0) laboratory abnormalities |
Secondary Outcome Measures
| Measure: | Phase I: Best Overall Response (BOR) |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression-free survival (PFS) |
| Time Frame: | from first dose to approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) |
| 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: | approximately 3 weeks (IMC-F106C AUC will be assessed for ~3 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The maximum observed plasma drug concentration (Cmax) |
| Time Frame: | approximately 3 weeks (IMC-F106C Cmax will be assessed for ~3 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The time to reach maximum plasma concentration (Tmax) |
| Time Frame: | approximately 3 weeks (IMC-F106C Tmax will be assessed for ~3 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Pharmacokinetics The elimination half-life (t1/2) |
| Time Frame: | approximately 3 weeks (IMC-F106C t1/2 will be assessed for ~ 3 weeks) |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-IMC-F106C antibody formation |
| Time Frame: | approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Changes in lymphocyte counts over time |
| Time Frame: | approximately 3 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Changes in serum cytokines over time |
| Time Frame: | approximately 3 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Immunocore Ltd |
Trial Keywords
- ImmTAC
- Immunotherapy
- Bispecific T cell receptor fusion protein
- Immune mobilizing monoclonal T cell receptor against cancer
- Checkpoint inhibitor
- PD1 / PD-1
- PD-L1 / PDL1
Last Updated
August 31, 2021
