Tests FOG-001 in adults with advanced solid tumors
Tests whether FOG-001 is safe and works in people with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: FOG-001 in Locally Advanced or Metastatic Solid Tumors
Key facts
- Where
- Melbourne and South Brisbane, AustraliaSee the 2 sites
- Phase
- Phase 1/2
Where in Australia
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
- Integrated Clinical Oncology Network (ICON)South Brisbane, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Parabilis Medicines, Inc.
- Trial code
- NCT05919264
- Record updated
- 7 October 2026
- Original description
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).Read full original descriptionShow less
A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
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).
Inclusion: 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: 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.