FOG-001 for Advanced or Metastatic Solid Tumors

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting Phase 1 Phase 2 Interventional Study
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
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?

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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.

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About This Trial

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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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-…
Contacts

Clinical Trial Inquiries

(857) 259-6305

clinicaltrials@parabilismed.com

CONTACT