Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion
Principal Investigator
by May Cho, MD (ucdavis)

Description

Summary

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

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 (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.

Keywords

Select Advanced Solid Tumors IMC-F106C anti-PD(L)1

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 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

Locations

  • University of California Davis Comprehenvise Center accepting new patients
    Sacramento California 95817 United States
  • Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States

Lead Scientist at UC Cancer

  • May Cho, MD (ucdavis)
    Assistant Professor, Internal Medicine. Authored (or co-authored) 27 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunocore Ltd
ID
NCT04262466
Phase
Phase 1/2
Study Type
Interventional
Last Updated