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 startedestimated 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.
- 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.
- 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
- ECOG PS 0 or 1
- HLA-A*02:01 positive
- PRAME positive tumor
- Relapsed from, refractory to, or intolerant of standard therapy
- If applicable, must agree to use highly effective contraception
- 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...
- Symptomatic or untreated central nervous system metastasis
- Recent bowel obstruction
- Ascites requiring recurrent paracentesis
- Significant immune-mediated adverse event with prior immunotherapy (patients in checkpoint inhibitor combination treatment)
- Inadequate washout from prior anticancer therapy
- Significant ongoing toxicity from prior anticancer treatment
- Out-of-range laboratory values
- Clinically significant lung, heart, or autoimmune disease
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