NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 595 (estimated)
• Sponsor: Parabilis Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a FIH, Phase 1/2, multicenter, open-label, non-randomized, dose escalation, dose expansion, and multiple subcutaneous dose study to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of FOG-001 as monotherapy and in combination with other anticancer agents in participants with advanced or metastatic solid tumors likely or known to have a Wnt pathway activating mutation (WPAM).

Conditions

• Cancer
• Colorectal Cancer
• Solid Tumor
• Locally Advanced Solid Tumor
• Metastatic Cancer
• WNT Pathway
• HCC
• Desmoid
• Microsatellite Stable Colorectal Cancer
• Metastatic Castration-resistant Prostate Cancer
• FAP
• Endometrial Carcinoma
• Prostate Cancer
• Microsatellite Instability-High Colorectal Cancer
• Adamantinomatous Craniopharyngioma

Interventions

Type	Name	Description
DRUG	FOG-001	FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
DRUG	mFOLFOX-6	mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
DRUG	Nivolumab	Nivolumab will be administered per the prescribing information in combination with FOG-001
DRUG	Trifluridine/tipiracil	Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
DRUG	Bevacizumab	Bevacizumab will be administered per the prescribing information in combination with FOG-001
DRUG	FOG-001	FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

Timeline

• Start date: 2023-05-23
• Primary completion: 2027-04-01
• Completion: 2027-08-31
• First posted: 2023-06-26
• Last updated: 2026-04-09

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study