Safety and Effectiveness of Experimental IMC-F106C for Advanced PRAME-Positive Cancers

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCSD UCSF
Dates
study started
estimated completion

Description

Summary

IMC-F106C is an immune-mobilizing monoclonal 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

Official Title

Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

Details

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 and administered in combination with a checkpoint Inhibitor, chemotherapy, or another ImmTAC molecule.
  2. Phase 2: To assess the efficacy of IMC-F106C as a single agent in selected advanced solid tumors.

Keywords

Select Advanced Solid Tumors, ImmTAC, Immunotherapy, Bispecific T cell receptor fusion protein, Immune mobilizing monoclonal T cell receptor against cancer, Checkpoint inhibitor, PD1 / PD-1, PD-L1 / PDL1, Melanoma, Lung Cancer, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer, NSCLC, Pembrolizumab, Atezolizumab, IMC-F106C, IMC-F106C and atezolizumab and pembrolizumab, IMC-F106C and chemotherapy, IMC-F106C and tebentafusp

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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 checkpoint inhibitor 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 lung, heart, or autoimmune 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 17. Any other contraindication for applicable combination partner based on local

    prescribing information

Locations

  • University of California Irvine not yet accepting patients
    Irvine California 92697 United States
  • University of California - San Diego not yet accepting patients
    La Jolla California 92093 United States
  • University of California Davis Comprehensive Center accepting new patients
    Sacramento California 95817 United States
  • University of California - San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Prisma Health accepting new patients
    Greenville South Carolina 92697 United States
  • Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunocore Ltd
ID
NCT04262466
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 170 study participants
Last Updated