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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 1e):

• 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):

• Diagnosis of HCC with a documented WPAM (by local testing) in APC or CTNNB1. HCC that is radiographically confirmed without tissue biopsy may be enrolled with a documented CTNNB1 mutation (e.g., by ctDNA).

⁃ Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d 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 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.

⁃ 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

Locations
United States
Arizona
Honor Health
RECRUITING
Scottsdale
California
Stanford Cancer Institute, Stanford University
RECRUITING
Palo Alto
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Johns Hopkins University, Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists
RECRUITING
Lake Mary
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center
RECRUITING
Cleveland
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center, Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
South Texas Accelerated Research Therapeutics, LLC
RECRUITING
San Antonio
Wisconsin
University of Wisconsin, Carbone Cancer Center
RECRUITING
Madison
Contact Information
Primary
Clinical Trial Inquiries
clinicaltrials@parabilismed.com
(857) 259-6305
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 575
Treatments
Experimental: Part 1a
Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
Experimental: Part 1b
MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 1c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Experimental: Part 1d-1
Desmoid Tumors
Experimental: Part 1d-2
Desmoid Tumors
Experimental: Part 1e-1
Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status
Experimental: Part 1e-2
Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status
Experimental: Part 1f-1
MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 1f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 1f-3
MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 2a
MSS CRC, irrespective of WPAM status
Experimental: Part 2b
Solid Tumors with documented WPAM
Experimental: Part 2c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Experimental: Part 2d
Desmoid Tumors
Experimental: Part 2e
Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
Experimental: Part 2f-1
MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 2f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Experimental: Part 2f-3
MSS CRC (known WPAM negative participants are not eligible)
Sponsors
Leads: Parabilis Medicines, Inc.

This content was sourced from clinicaltrials.gov