Recruiting
Phase 1
Phase 2

FOG-001

Sponsor:

Parabilis Medicines, Inc.

Code:

NCT05919264

Conditions

Cancer

Colorectal Cancer

Solid Tumor

Locally Advanced Solid Tumor

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FOG-001

mFOLFOX-6

Nivolumab

Trifluridine/tipiracil

Bevacizumab

Study Details

Brief 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).

Conditions

Cancer

Colorectal Cancer

Solid Tumor

Locally Advanced Solid Tumor

Metastatic Cancer

Study ID

NCT05919264

Start date

May 23, 2023

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

619 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 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 1g

Solid Tumors with documented WPAM (known WPAM negative participants are not eligible)

experimental: Part 1h

Desmoid Tumors

experimental: Part 1i

Familial adenomatous polyposis (FAP)

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)

Interventions

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

Primary outcome measure

  • During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0 [ Time Frame: Through study completion, an average of 10 months ]
  • During dose escalation characterize dose-limiting toxicities (DLTs) [ Time Frame: 1 treatment cycle (28 days) ]
  • During dose expansion describe the Overall Response Rate using RECIST v1.1 [ Time Frame: Every 63 days until study completion, approximately 10 months on average ]
  • During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only) [ Time Frame: 4 months ]
  • During dose expansion describe the PSA30 response rate for participants with prostate cancer [ Time Frame: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months) ]

Central Contacts and Locations

Central contacts

Clinical Trial Inquiries

(857) 259-6305clinicaltrials@parabilismed.com

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Mahesh Seetharam, MD

480-301-8000

Honor Health

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Sunil Sharma, MD

480-323-1350

Arizona Cancer Center at University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Aaron Scott, MD

520-694-2873

University of California, Los Angeles (UCLA)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Randy Hecht, MD

310-829-5471

Stanford Cancer Institute, Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Nam Bui

650-498-6000

University of California San Francisco, Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Phu Lam

888-689-8273

Sarcoma Oncology Center

Recruiting

Santa Monica, California, United States, 90403

Contacts

Sant Chawla, MD

301-552-9999

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Breelyn Wilky, MD

305-243-1287

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Michael Cecchini, MD

415-302-7807

Johns Hopkins University, Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Mike J Pishvaian, MD/PhD

202-804-3343

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Conor O'Donnell, MD

904-953-6870

Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Mike J Pishvaian, MD/PhD

410-955-8964

Eric Christenson, MD

410-955-8964

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Samuel Klempner, MD

617-724-4000

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Candace Haddox, MD

617-632-3000

M Health Fairview University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Ajay Prakash, MD/PhD

612-273-8383

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Hao Xie, MD

504-284-2511

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Moh'd Khushman, MD

314-362-9115

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Rona Yaeger, MD

646-888-5109

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Niharika Mettu, MD

919-684-6342

University Hospitals Cleveland Medical Center, Seidman Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

David Bajor, MD

216-765-9033

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Wen Wee Ma, MBBS

216-444-2200

Dale Shepard, MD, PhD

(216) 444-2200

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Shivaani Kummar, MD

503-494-8534

University of Pennsylvania, Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mark O'Hara, MD

215-662-4646

University of Pittsburgh Medical Center, Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Dennis J Hsu, MD

412-623-1722

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Meredith S Pelster, MD

615-329-6862

Vanderbilt Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Kristen Ciombor, MD

615-322-3000

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jordi Rodon Ahnert, MD/PhD

713-792-5603

South Texas Accelerated Research Therapeutics, LLC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kyriakos Papadopoulos, MD

210-593-5255

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Ludimila Cavalcante, MD

434-358-8780

University of Wisconsin, Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Jeremy Kratz, MD

608-263-1300

More Information

Sponsor

Parabilis Medicines, Inc.

Last update posted

Aug 17, 2026

Last verified

Jul, 2026

Keywords

  • Cancer
  • Solid Tumor
  • Locally Advanced Solid Tumor
  • Metastatic Cancer
  • WNT Pathway Activating Mutation (WPAM)
  • Colorectal Cancer (CRC)
  • Microsatellite Stable (MSS)
  • Desmoid
  • Hepatocellular Carcinoma (HCC)
  • Adenomatous Polyposis Coli (APC)
  • β-catenin
  • Beta-catenin
  • CTNNB1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Parabilis Medicines, Inc. on 2026-08-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.