Health Trials

FOG-001 in Locally Advanced or Metastatic Solid Tumors

ConditionsCancerColorectal CancerSolid TumorLocally Advanced Solid TumorMetastatic CancerWNT PathwayHCCDesmoidMicrosatellite Stable Colorectal CancerMetastatic Castration-resistant Prostate CancerFAPEndometrial CarcinomaProstate CancerMicrosatellite Instability-High Colorectal CancerAdamantinomatous Craniopharyngioma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorParabilis Medicines, Inc.

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.

Eligibility criteria

Qualifiers

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

Adequate organ and marrow function.

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).

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

Disqualifiers

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

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)

Trial design

Treatments tested in this trial

  • FOG-001
  • mFOLFOX-6
  • Nivolumab
  • Trifluridine/tipiracil
  • Bevacizumab
  • FOG-001

Treatment groups

595 Participants
are divided into 18 treatment groups

18

Treatment groups

See each treatment group below.

Sponsors and collaborators

Parabilis Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov