FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor, Metastatic Cancer, WNT Pathway, HCC, Desmoid, Microsatellite Stable Colorectal Cancer, Metastatic Castration-resistant Prostate Cancer, Familial Adenomatous Polyposis (FAP), Endometrial Carcinoma, Prostate Cancer, Microsatellite Instability-High Colorectal Cancer, Adamantinomatous Craniopharyngioma

In brief

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).

Key facts

Study ID

NCT05919264

Run by

Parabilis Medicines, Inc.

People needed

619

Starts

2023-05-23

Expected to finish

2027-08-31

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 CTNNB1
• Additional 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 CRC
• Participants 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-L1
• Participants 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 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) CRC
• Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
• Monotherapy Dose Optimization (Part 1i): FAP
• Diagnosis of phenotypic classical FAP with a documented APC mutation
• Post-colectomy >6 months prior to first dose of study drug administration with measurable duodenal polyp burden

You may not qualify if…

• Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed.
• 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.
• Complete colectomy within 6 months of the first dose of study drug administration.

Where it is running

• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Honor Health — Scottsdale, Arizona, United States (enrolling)
• Arizona Cancer Center at University of Arizona — Tucson, Arizona, United States (enrolling)
• University of California, Los Angeles (UCLA) — Los Angeles, California, United States (enrolling)
• Stanford Cancer Institute, Stanford University — Palo Alto, California, United States (enrolling)
• University of California San Francisco, Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• Sarcoma Oncology Center — Santa Monica, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Johns Hopkins University, Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Mayo Clinic — Phoenix, Arizona, United States (enrolling)
• Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center, Seidman Cancer Center — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center, Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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