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Phase I-II

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

  • Study HIC#:2000035663
  • Last Updated:08/06/2024

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    Trial Purpose and Description

    This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF) family of transcription factors.

    Eligibility Criteria

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Adequate organ and marrow function.

    Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a):

    • Diagnosis of treatment-refractory advanced/metastatic solid tumor that is non-MSI-H or non-dMMR colorectal cancer (CRC) or any other solid tumor with documented WNT- pathway activating mutations (WPAMs).

    Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):

    • Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
    • At least one lesion that is suitable for a core needle biopsy.

    Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2a): Colorectal Cancer (CRC) Cohort

    • Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.

    Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2b): Non-small Cell Lung Cancer (NSCLC) Cohort

    • Diagnosis of treatment-refractory advanced/metastatic NSCLC with documented WPAMs in adenomatous polyposis coli (APC) or Beta-catenin.

    Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2c): Gastric/Gastroesophageal junction (GEJ) Cohort

    • Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with documented WPAMs in APC or Beta-catenin.

    Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2d): Tumor Agnostic Cohort

    • Diagnosis of treatment-refractory advanced/metastatic solid tumor with documented WPAMs.

    Exclusion Criteria:

    • Known history of bone metastasis.
    • Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months.
    • Osteoporosis, which is defined as a T-score of <-2.0 at the lumbar spine (L1 - L4), left (or right) femoral neck, and left (or right) total hip as determined by DXA scan.
    • Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently.
    • Unstable/inadequate cardiac function.
    • Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.
    • Pregnant, lactating, or planning to become pregnant.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: