RecruitingPhase 1/2

FOG-001 in Locally Advanced or Metastatic Solid Tumors

United States, Australia595 participantsStarted 2023-05-23

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 allow…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0

Timeframe: Through study completion, an average of 10 months

During dose escalation characterize dose-limiting toxicities (DLTs)

Timeframe: 1 treatment cycle (28 days)

During dose expansion describe the Overall Response Rate using RECIST v1.1

Timeframe: Every 63 days until study completion, approximately 10 months on average

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

Timeframe: 4 months

During dose expansion describe the PSA30 response rate for participants with prostate cancer

Timeframe: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)

Trial details

NCT IDNCT05919264

SponsorParabilis Medicines, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Clinical Trial Inquiries

(857) 259-6305 clinicaltrials@parabilismed.com

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