Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
575 participants
INTERVENTIONAL
2023-05-23
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a
Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1b
MSS CRC (known WPAM negative participants are not eligible)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1d-1
Desmoid Tumors
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1d-2
Desmoid Tumors
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1e-1
Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1e-2
Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 1f-1
MSS CRC (known WPAM negative participants are not eligible)
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
Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Part 1f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Nivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
Part 1f-3
MSS CRC (known WPAM negative participants are not eligible)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
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
Part 2a
MSS CRC, irrespective of WPAM status
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 2b
Solid Tumors with documented WPAM
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 2c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 2d
Desmoid Tumors
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 2e
Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Part 2f-1
MSS CRC (known WPAM negative participants are not eligible)
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
Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Part 2f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Nivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
Part 2f-3
MSS CRC (known WPAM negative participants are not eligible)
FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ and marrow function.
* 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).
* 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.
* 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).
* Desmoid tumor (aggressive fibromatosis)
* 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.
* 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
* 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.
* Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
* Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Parabilis Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jorge Ramos, DO
Role: STUDY_CHAIR
Parabilis Medicines, Inc.
Locations
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Honor Health
Scottsdale, Arizona, United States
Stanford Cancer Institute, Stanford University
Palo Alto, California, United States
University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Johns Hopkins University, Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center, Seidman Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Wisconsin, Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Sunil Sharma, MD
Role: primary
Nam Bui
Role: primary
Varun Monga, MD
Role: primary
Sant Chawla, MD
Role: primary
Michael Cecchini, MD
Role: primary
Mike J Pishvaian, MD/PhD
Role: primary
Alexander Philipovskiy, MD/PhD
Role: primary
Mike J Pishvaian, MD/PhD
Role: primary
Eric Christenson, MD
Role: backup
Samuel Klempner, MD
Role: primary
Candace Haddox, MD
Role: primary
Ajay Prakash, MD/PhD
Role: primary
Moh'd Khushman, MD
Role: primary
Rona Yaeger, MD
Role: primary
David Bajor, MD
Role: primary
Wen Wee Ma, MBBS
Role: primary
Dale Shepard, MD, PhD
Role: backup
Shivaani Kummar, MD
Role: primary
Dennis J Hsu, MD
Role: primary
Meredith S Pelster, MD
Role: primary
Jordi Rodon Ahnert, MD/PhD
Role: primary
Kyriakos Papadopoulos, MD
Role: primary
Ludimila Cavalcante, MD
Role: primary
Jeremy Kratz, MD
Role: primary
Other Identifiers
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FOG-001-101
Identifier Type: -
Identifier Source: org_study_id
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