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

Study Identifier:
FOG-001-101
CT.gov Identifier:
NCT05919264
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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

To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. with an Initial focus on colorectal cancer (CRC)

Phase 1 portion: To assess the safety and tolerability of FOG-001 across a range of dose levels to determine the best doses to progress to the Phase 2 portion.

Phase 2 portion: To evaluate the safety, tolerability and anti-tumor activity of single-agent FOG-001 at the recommended Phase 2 dose

To evaluate the safety/tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor effects of FOG-001 as monotherapy and in combination with other anti-cancer therapies.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Bowel (Colorectal)
  • Solid Tumor
  • Metastatic Cancer
  • Liver
  • Prostate
  • Gene Mutations
  • Endometrial
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1a
    • Read More
  • Drug: Experimental: Part 1f-2
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion 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 and Part 1g):
    • 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 Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):
    • Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):
    • Desmoid tumor (aggressive fibromatosis)Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:
    • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRCParticipants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab
    • Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligibleAdditional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab
    • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRCParticipants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):
    • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRCAdditional Inclusion Criteria for Dose Expansion Cohort (Part 2b):
    • Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
    Exclusion criteria
    • Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.
    • Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.
    • Osteoporosis, which is defined as a T-score of ≤-2.5 at the lumbar spine (L1 - L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan.
    • Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
    • 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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Bowel (Colorectal)
    Solid Tumor
    Metastatic Cancer
    Liver
    Prostate
    Gene Mutations
    Endometrial