Clinical Trial 22306

• 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

  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

  Objective:

  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

  Therapies:

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

  Medications:

  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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