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FOG-001 in Locally Advanced or Metastatic Solid Tumors

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full 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 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

Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):

* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC

Additional 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. 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.

About the study

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).

What is being tested

Sponsor: Parabilis Medicines, Inc. · Participants: 619 · Started: May 23, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05919264

Locations in the U.S.

ArizonaMayo Clinic, Phoenix
Honor Health, Scottsdale
Arizona Cancer Center at University of Arizona, Tucson
CaliforniaUniversity of California, Los Angeles (UCLA), Los Angeles
Stanford Cancer Institute, Stanford University, Palo Alto
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco
Sarcoma Oncology Center, Santa Monica
ColoradoUniversity of Colorado, Aurora
ConnecticutYale University School of Medicine, New Haven
District of ColumbiaJohns Hopkins University, Sibley Memorial Hospital, Washington D.C.
FloridaMayo Clinic, Jacksonville
MarylandJohns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center, Baltimore
MassachusettsDana Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MinnesotaM Health Fairview University of Minnesota Medical Center, Minneapolis
Mayo Clinic, Rochester
MissouriWashington University School of Medicine, St Louis
New YorkMemorial Sloan Kettering Cancer Center, New York
North CarolinaDuke University, Durham
OhioCleveland Clinic, Cleveland
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland
OregonOregon Health and Science University, Portland
PennsylvaniaUniversity of Pennsylvania, Perelman School of Medicine, Philadelphia
University of Pittsburgh Medical Center, Hillman Cancer Center, Pittsburgh
TennesseeSarah Cannon Research Institute, Nashville
Vanderbilt Ingram Cancer Center, Nashville
TexasThe University of Texas MD Anderson Cancer Center, Houston
South Texas Accelerated Research Therapeutics, LLC, San Antonio
VirginiaUniversity of Virginia, Charlottesville
WisconsinUniversity of Wisconsin, Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.