Clinical Trials /

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

NCT04262466

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
IMC-F106CIMC-F106C - Arm A - Phase 1
anti-PD(L)1IMC-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

NameTypeDescriptionInterventions
IMC-F106C - Arm A - Phase 1ExperimentalDose Escalation
  • IMC-F106C
IMC-F106C and an anti-PD(L)1 agent - Arm B - Phase 1ExperimentalDose Escalation
  • IMC-F106C
  • anti-PD(L)1
IMC-F106C - Phase 2ExperimentalMonotherapy dose expansion
  • IMC-F106C

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 cardiac disease

          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 of anemia, activated partial thromboplastin time prolonged, alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hemoglobin increased, INR increased, lipase increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, serum amylase increased, white blood cell decreased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, chronic kidney disease, proteinuria.

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:Not yet recruiting
Lead Sponsor:Immunocore Ltd

Last Updated

February 7, 2020