No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
619 (estimated)
Sponsor
Parabilis Medicines, Inc. · Industry
Who this trial is looking for
This trial is looking for people with advanced or metastatic solid tumors, including certain types of colon and prostate cancers, or familial adenomatous polyposis. Participants will receive a new treatment called FOG-001 to see if it is safe and effective.
Are You a Good Fit for This Trial?
You may be able to join if
I have a performance status of 0 or 1.
I have adequate organ and marrow function.
I have a diagnosis of advanced or metastatic solid tumor.
I have a documented WNT-pathway activating mutation.
I have a diagnosis of familial adenomatous polyposis with an APC mutation.
I have at least one lesion suitable for a biopsy.
You may not be able to join if
I have a known history of bone metastasis, except for mCRPC.
I have had a bone fracture in the past 12 months.
I have osteoporosis.
I have uncontrolled inflammatory bowel disease.
I have unstable or inadequate cardiac function.
I have known brain metastases or spinal cord compression.
I am pregnant, lactating, or planning to become pregnant.
I have had a complete colectomy within 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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City
State
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Status
Eligibility Criteria
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-…
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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