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FOG-001 for Advanced Solid Tumors and Colorectal Cancer

This study is testing a new drug called FOG-001 for people with locally advanced or metastatic (spread to other parts of the body) solid tumors, including colorectal cancer. Researchers want to see if FOG-001 is safe and how well it works, both on its own and when combined with other cancer treatments like mFOLFOX-6, Nivolumab, Trifluridine/tipiracil, or Bevacizumab. You might be able to join if you are 18 or older, have a good general health status (ECOG performance status of 0 or 1), and have adequate organ and bone marrow function. For some parts of the study, you might need to have a specific type of solid tumor that has not responded to previous treatments, or a WNT-pathway activating mutation. The study will look at side effects, how much of the drug can be given safely, and how much tumors shrink.

Study design
This is an open-label (you and your doctors will know what treatment you are receiving) study with no specified phase, aiming to enroll 619 participants. It involves increasing doses of FOG-001 and expanding to more participants once a safe dose is found.
What's involved
FOG-001 will be given through an IV in 28-day cycles. Other medications will be given as prescribed. The study will monitor side effects throughout, and tumor responses will be checked every 63 days until the study ends, which is approximately 10 months on average.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be monitored through study completion, which is an average of 10 months. Tumor responses will be measured every 63 days until study completion, approximately 10 months on average.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Parabilis Medicines, Inc.
~619 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:FOG-001mFOLFOX-6NivolumabTrifluridine/tipiracilBevacizumab

At a glance

Recruiting sites
32 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Measured over Through study completion, an average of 10 months
+4 more outcomes measured

Conditions

Cancer
Colorectal Cancer
Solid Tumor
Locally Advanced Solid Tumor
Metastatic Cancer
WNT Pathway
HCC
Desmoid
Microsatellite Stable Colorectal Cancer
Metastatic Castration-resistant Prostate Cancer
Familial Adenomatous Polyposis (FAP)
Endometrial Carcinoma
Prostate Cancer
Microsatellite Instability-High Colorectal Cancer
Adamantinomatous Craniopharyngioma

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Where it's being run

33 sites across 21 states
California4
Arizona3
Florida2
Massachusetts2
Minnesota2
Ohio2
Pennsylvania2
Tennessee2

Study leadership

  • Benjamin Oshrine · STUDY_CHAIR · Parabilis Medicines, Inc.

Who to contact

Clinical Trial Inquiries
[email protected]
(857) 259-6305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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.
Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1
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 with or without bevacizumab 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 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
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

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.

What this trial measures

  • During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0Through study completion, an average of 10 months

    Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0

  • During dose escalation characterize dose-limiting toxicities (DLTs)1 treatment cycle (28 days)

    Incidence of DLTs

  • During dose expansion describe the Overall Response Rate using RECIST v1.1Every 63 days until study completion, approximately 10 months on average

    The rate of objective responses (Partial \& Complete) using RECIST v1.1

  • During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)4 months

    The rate of objective responses (Stable, Partial, \& Complete) using RECIST v1.1

  • During dose expansion describe the PSA30 response rate for participants with prostate cancerBaseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)

    The response to treatment as a 30% or greater reduction in PSA levels from baseline