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

View Full Description

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 13 Locations for this study

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Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Roland Menendez
Contact
Omid Hamid, MD
Principal Investigator
University of California Davis Comprehensive Center
Sacramento California, 95817, United States More Info
Laura Molnar
Contact
Frances Lara
Contact
Hui Amy Chen, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Michael Cournoyer
Contact
[email protected]
Columbia University Medical Center
New York New York, 10032, United States More Info
Suzanne Mistretta
Contact
Elizabeth Vann
Contact
Benjamin Izar, MD
Principal Investigator
Memorial Sloan Kettering
New York New York, 10065, United States More Info
Samantha Smith
Contact
Margaret Callahan, MD
Principal Investigator
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Sarah Homan
Contact
Kiersten During
Contact
Raid Aljumaily, MD
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Kathrine Senter
Contact
Taylor Holton
Contact
Takami Sato, MD
Principal Investigator
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Sarah Brodeur
Contact
Diwakar Davar, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Whitney Burroughs
Contact
Melissa Johnson, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jeane Painter
Contact
Jessica Catrett
Contact
Ectaerina Dumbrava, MD
Principal Investigator
Sarah Cannon Research Institute UK
London City Of London, W1G6A, United Kingdom More Info
Maria Victoria Borja Beral
Contact
Juan Pedro Navarro Garcia
Contact
Anja Williams, MD
Principal Investigator
University College Hospital London
London , W1T7H, United Kingdom More Info
Shazia Begum
Contact
Heather Shaw, MD
Principal Investigator
The Christie NHS Foundation Trust
Manchester , , United Kingdom More Info
Jessica Ritchie
Contact
Schweta Vyas
Contact
Fiona Thistlethwaite
Principal Investigator
Royal Marsden Hospital
Surrey Quays , SM25P, United Kingdom More Info
Dan Bar
Contact
Mahesha Ganegoda
Contact
Juanita Lopez, MD
Principal Investigator

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

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