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  • Cancer Type: Multiple
  • Study Type: Treatment
  • NCT#: NCT04262466
  • Phase: Phase I/II
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  • Overview

    Study Title:

    A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers


    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


    Primary (Phase 1) * To assess the safety and tolerability of IMC-F106C and identify the MTD and/or RP2D of IMC-F106C as monotherapy administered IV and SC and in combination with a checkpoint inhibitor, chemotherapy, or another ImmTAC molecule in advanced solid tumors * To characterize the initial efficacy of IMC-F106C as monotherapy in selected advanced solid tumors Primary (Phase 2) * To characterize the efficacy of IMC-F106C as monotherapy in selected advanced solid tumors

  • Treatments


    Antibody-Drug Conjugate; Chemotherapy (NOS); Immunotherapy; Therapy (NOS)


    AZD9291 (Osimertinib); Alimta (Pemetrexed); Atezolizumab (Tecentriq); Avastin (Bevacizumab); Bevacizumab (); GSK2118436 (dabrafenib); Gemzar (gemcitabine); IMC-F106C (); Nab-paclitaxel (Abraxane); Osimertinib (); PEGylated Liposomal Doxorubicin (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Taxol (paclitaxel); Taxotere (docetaxel); Tebentafusp (); biologic (); carboplatin (); dabrafenib (); decitabine (5-aza-2'-deoxycytidine); docetaxel (); gemcitabine (); paclitaxel ()

  • Inclusion 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.
    • Other criteria may apply.
  • Exclusion Criteria

      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 as defined in protocol
    • 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

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