FOG-001 in Locally Advanced or Metastatic Solid Tumors

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug
  • PHASE1/PHASE2
  • Parabilis Medicines, Inc.
  • 18 Years -


Study Purpose

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

Intervention

Drug : FOG-001

Drug : mFOLFOX-6

Drug : Nivolumab

Drug : Trifluridine/tipiracil

Drug : Bevacizumab


Eligibility Requirements

info icon Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

info icon Adequate organ and marrow function.

info icon Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1a and Part 1e):

info icon 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).

info icon Additional Inclusion Criteria for Dose Escalation Cohorts (Part 1b):

info icon Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.

info icon At least one lesion that is suitable for a core needle biopsy.

info icon Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):

info icon Diagnosis of HCC with a documented WPAM (by local testing) in APC or CTNNB1. HCC that is radiographically confirmed without tissue biopsy may be enrolled with a documented CTNNB1 mutation (e.g., by ctDNA).

info icon Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d and Part 2d):

info icon Desmoid tumor (aggressive fibromatosis) with a documented WPAM (by local testing) in APC or CTNNB1.

info icon Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:

info icon Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC

info icon Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.

info icon Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab

info icon Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.

info icon MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1

info icon Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible

info icon Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab

info icon Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC

info icon Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.

info icon Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):

info icon Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC

info icon Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b):

info icon Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence

info icon Minimum age: 18

info icon Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.

info icon Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.

info icon 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.

info icon Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently.

info icon Unstable/inadequate cardiac function.

info icon Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.

info icon Pregnant, lactating, or planning to become pregnant.

Recruiting status

Recruiting

Estimated enrollment

480

 
Study start date

May 23, 2023

Study end date

Aug 31, 2027

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1/PHASE2

Allocation

Non Randomized

 

Sponsor:

Parabilis Medicines, Inc.

Collaborator:

N/A

Investigator:

Marie Nguyen, MD

NCT05919264

Clinic Location Investigator Distance RECRUITING STATUS Contact