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Clinical Trials in the USA / NCT05919264
Recruiting Phase 1/2

FOG-001 in Locally Advanced or Metastatic Solid Tumors

NCT05919264 · tracked via the Priya Life Science USA tracker
Sponsor
Parabilis Medicines, Inc.
Phase
Phase 1/2
Started
2023-05-23
Last updated
2026-08-17

Condition(s) studied

CancerColorectal CancerSolid TumorLocally Advanced Solid TumorMetastatic CancerWNT PathwayHCCDesmoidMicrosatellite Stable Colorectal CancerMetastatic Castration-resistant Prostate CancerFamilial Adenomatous Polyposis (FAP)Endometrial CarcinomaProstate CancerMicrosatellite Instability-High Colorectal CancerAdamantinomatous Craniopharyngioma

Investigational drug(s) / intervention(s)

FOG-001mFOLFOX-6NivolumabTrifluridine/tipiracilBevacizumabFOG-001

FOG-001: FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days

mFOLFOX-6: mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001

Nivolumab: Nivolumab will be administered per the prescribing information in combination with FOG-001

Trifluridine/tipiracil: Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001

Bevacizumab: Bevacizumab will be administered per the prescribing information in combination with FOG-001

FOG-001: FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

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 solid tumors or in participants with familial adenomatous polyposis (FAP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Recruiting
Honor Health Scottsdale Arizona Recruiting
Arizona Cancer Center at University of Arizona Tucson Arizona Recruiting
University of California, Los Angeles (UCLA) Los Angeles California Recruiting
Stanford Cancer Institute, Stanford University Palo Alto California Recruiting
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Sarcoma Oncology Center Santa Monica California Recruiting
University of Colorado Aurora Colorado Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
Johns Hopkins University, Sibley Memorial Hospital Washington D.C. District of Columbia Recruiting
Mayo Clinic Jacksonville Florida Recruiting
Florida Cancer Specialists Lake Mary Florida Terminated
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University Durham North Carolina Recruiting
University Hospitals Cleveland Medical Center, Seidman Cancer Center Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Oregon Health and Science University Portland Oregon Recruiting
University of Pennsylvania, Perelman School of Medicine Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center, Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Vanderbilt Ingram Cancer Center Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
South Texas Accelerated Research Therapeutics, LLC San Antonio Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
University of Wisconsin, Carbone Cancer Center Madison Wisconsin Recruiting
Integrated Clinical Oncology Network (ICON) South Brisbane Queensland Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting

On this site

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05919264 on ClinicalTrials.gov ↗ ← All trials in the USA