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 UCSD
Dates
study started
completion around

Description

Summary

Brenetafusp (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 brenetafusp 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 brenetafusp as a single agent and administered in combination with chemotherapies, targeted therapies, and monoclonal antibodies.
  2. Phase 2: To assess the efficacy of brenetafusp in selected advanced solid tumors.

Keywords

Select Advanced Solid Tumors, Bevacizumab, Pembrolizumab, Antibodies, Monoclonal Antibodies, Brenetafusp, Brenetafusp and pembrolizumab, Brenetafusp and chemotherapy, Brenetafusp and monoclonal antibodies and chemotherapy, Brenetafusp and tebentafusp, Brenetafusp and bevacizumab, Brenetafusp and kinase inhibitors, Brenetafusp Monotherapy, Brenetafusp and Anti-PD(L)1 Agent, Brenetafusp and Targeted Therapy, Brenetafusp and Multimodal Therapy

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 therapies; or, in combination with standard therapies
  5. If applicable, must agree to use highly effective contraception

You CAN'T join if...

  1. Symptomatic or untreated central nervous system metastasis
  2. Recent bowel obstruction
  3. Ongoing ascites or effusion requiring recent drainages
  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), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  12. Significant secondary malignancy
  13. Hypersensitivity to study drug or excipients
  14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
  15. Pregnant or lactating
  16. Any other contraindication for applicable combination partner based on local prescribing information

Locations

  • University of California - San Diego accepting new patients
    La Jolla California 92093 United States
  • University of California Davis Comprehensive Center accepting new patients
    Sacramento California 95817 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 727 study participants
Last Updated