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New drug FOG-001 takes on Hard-to-Treat cancers

NCT ID NCT05919264

Disease control Sponsor: Parabilis Medicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This early-phase trial is testing a new drug, FOG-001, in about 595 people with advanced or metastatic solid tumors, including colorectal, prostate, and liver cancers. The drug is given alone or with other cancer treatments to see if it is safe and shrinks tumors. The study is currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FOG-001 (a drug given intravenously, sometimes combined with chemotherapy or other cancer drugs)
What this could lead to
If it works, this could point toward a new treatment option for several types of advanced solid tumors that are hard to treat.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. There is no guarantee the drug will work or be safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 619 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adamantinous craniopharyngioma Adenomatous Polyposis Coli cancer castration-resistant prostate carcinoma classic familial adenomatous polyposis colorectal cancer colorectal carcinoma colorectal neoplasm craniopharyngioma desmoid tumor endometrial carcinoma endometrium neoplasm familial adenomatous polyposis 1 hepatocellular carcinoma Lynch syndrome metastatic malignant neoplasm metastatic prostate carcinoma neoplasm Neoplasm Metastasis prostate cancer severe intellectual disability-progressive spastic diplegia syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adamantinomatous craniopharyngioma Adenomatous polyposis coli APC Beta-catenin Cancer Colorectal cancer CTNNB1 Desmoid Endometrial carcinoma Familial adenomatous polyposis (FAP) FAP HCC Locally advanced solid tumor Metastatic cancer Metastatic castration resistant prostate cancer Microsatellite instability-high colorectal cancer Microsatellite-stable colorectal cancer Prostate cancer Solid tumor WNT pathway Β-catenin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Cancer Center at University of Arizona

    RECRUITING

    Tucson, Arizona, 85719, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Florida Cancer Specialists

    TERMINATED

    Lake Mary, Florida, 32746, United States

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Integrated Clinical Oncology Network (ICON)

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Johns Hopkins University, Sibley Memorial Hospital

    RECRUITING

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

  • Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • M Health Fairview University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarcoma Oncology Center

    RECRUITING

    Santa Monica, California, 90403, United States

  • South Texas Accelerated Research Therapeutics, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Stanford Cancer Institute, Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University Hospitals Cleveland Medical Center, Seidman Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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

    RECRUITING

    San Francisco, California, 94158, United States

  • University of California, Los Angeles (UCLA)

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania, Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center, Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin, Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Vanderbilt Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06520, United States

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