Melanoma Clinical Trial

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

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

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Full 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.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Prior solid organ or bone marrow transplant
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Known history of human immunodeficiency virus (HIV)
Significant secondary malignancy
Hypersensitivity to study drug or excipients
Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention
Pregnant or lactating
Any other contraindication for applicable combination partner based on local prescribing information

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT04262466

Recruitment Status:

Recruiting

Sponsor:

Immunocore Ltd

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There are 29 Locations for this study

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Honor Health
Scottsdale Arizona, 85258, United States
University of California Irvine
Irvine California, 92697, United States
University of California - San Diego
La Jolla California, 92093, United States
Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
University of California Davis Comprehensive Center
Sacramento California, 95817, United States
University of California - San Francisco
San Francisco California, 94143, United States
University of Colorado
Aurora Colorado, 80045, United States
Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20057, United States
Houston Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory university
Atlanta Georgia, 30322, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
University of Iowa
Iowa City Iowa, 52242, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering
New York New York, 10065, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Washington - Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
University of Wisconsin
Madison Wisconsin, 53705, United States
Sarah Cannon Research Institute UK
London City Of London, W1G6A, United Kingdom
University of Oxford
Oxford Oxfordshire, OX3 7, United Kingdom
University College Hospital London
London , W1T7H, United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom
Royal Marsden Hospital
Surrey Quays , SM25P, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

170

Study ID:

NCT04262466

Recruitment Status:

Recruiting

Sponsor:


Immunocore Ltd

How clear is this clinincal trial information?

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