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Taking people in AustraliaPhase 1/2

Tests FOG-001 in adults with advanced solid tumors

Tests whether FOG-001 is safe and works in people with advanced solid tumors.

Key facts

Who runs it
Parabilis Medicines, Inc.
Where
Melbourne and South Brisbane, AustraliaSee the 2 sitesAlso in 1 other country, 31 sites
Trial code
Registry title
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
619 people, planned
Started
23 May 2023
Expected to end
31 Aug 2027
Type of study
Interventional, 19 groups
Treatments tested
  • FOG-001
  • mFOLFOX-6
  • Nivolumab
  • Trifluridine/tipiracil
  • Bevacizumab
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or spread solid tumors, such as colorectal cancer, liver cancer or desmoid tumor, or with familial adenomatous polyposis (FAP). It tests FOG-001, alone or with other drugs.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced or metastatic solid tumors. Depending on the part of the trial: colorectal cancer that is not MSI-H or dMMR, liver cancer (HCC), desmoid tumor, or classical FAP. Some parts need treatment-refractory disease.
Earlier treatment
Some parts need cancer that no longer responds to treatment. For FOG-001 with FOLFOX and bevacizumab, up to one earlier dose of mFOLFOX6 is allowed. For FAP, the colon must have been removed more than 6 months before the first dose.
Biomarker or test result
Some parts need a documented WNT-pathway activating mutation, or an APC or CTNNB1 mutation. Tumors known to be negative for APC or CTNNB1 mutations cannot join the combination parts. FAP needs a documented APC mutation.

Main reasons for not taking part

  • Known history of bone metastasis (allowed in prostate cancer and for osteomas in FAP)
  • Recent vertebral compression fracture or non-traumatic bone fracture without bone-protecting treatment
  • Osteoporosis found on a bone scan
  • Uncontrolled inflammatory bowel disease
  • Pregnant, breastfeeding, or planning to become pregnant

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy
  • Complete colectomy within 6 months of the first dose of study drug administration
  • Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC. For participants with FAP, osteomas are allowed
  • Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
  • Unstable/inadequate cardiac function
  • 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
  • Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases
  • Pregnant, lactating, or planning to become pregnant

Where in Australia

Also in 1 other country, 31 sites

  • Peter MacCallum Cancer CentreMelbourne, AustraliaContact: Jeremy Lewin, MDTaking people
  • Integrated Clinical Oncology Network (ICON)South Brisbane, AustraliaContact: Vladimir Andelkovic, MDTaking people

About the trial

What the trial wants to find out

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).

The 19 groups in the trial

  • Part 1aTreatment being tested

    Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status

    Treatment: FOG-001

  • Part 1bTreatment being tested

    MSS CRC (known WPAM negative participants are not eligible)

    Treatment: FOG-001

  • Part 1cTreatment being tested

    Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

    Treatment: FOG-001

  • Part 1d-1Treatment being tested

    Desmoid Tumors

    Treatment: FOG-001

  • Part 1d-2Treatment being tested

    Desmoid Tumors

    Treatment: FOG-001

  • Part 1f-1Treatment being tested

    MSS CRC (known WPAM negative participants are not eligible)

    Treatment: FOG-001, mFOLFOX-6, and Bevacizumab

  • Part 1f-2Treatment being tested

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

    Treatment: FOG-001 and Nivolumab

  • Part 1f-3Treatment being tested

    MSS CRC (known WPAM negative participants are not eligible)

    Treatment: FOG-001, Trifluridine/tipiracil, and Bevacizumab

  • Part 1gTreatment being tested

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

    Treatment: FOG-001

  • Part 1hTreatment being tested

    Desmoid Tumors

    Treatment: FOG-001

  • Part 1iTreatment being tested

    Familial adenomatous polyposis (FAP)

    Treatment: FOG-001

  • Part 2aTreatment being tested

    MSS CRC, irrespective of WPAM status

    Treatment: FOG-001

  • Part 2bTreatment being tested

    Solid Tumors with documented WPAM

    Treatment: FOG-001

  • Part 2cTreatment being tested

    Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

    Treatment: FOG-001

  • Part 2dTreatment being tested

    Desmoid Tumors

    Treatment: FOG-001

  • Part 2eTreatment being tested

    Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)

    Treatment: FOG-001

  • Part 2f-1Treatment being tested

    MSS CRC (known WPAM negative participants are not eligible)

    Treatment: FOG-001, mFOLFOX-6, and Bevacizumab

  • Part 2f-2Treatment being tested

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

    Treatment: FOG-001 and Nivolumab

  • Part 2f-3Treatment being tested

    MSS CRC (known WPAM negative participants are not eligible)

    Treatment: FOG-001, Trifluridine/tipiracil, and Bevacizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Plain-language title
Tests FOG-001 in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
7 October 2026