A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors
Parabilis Medicines, Inc.
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.
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 th…
Interventions
- DrugFOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
- DrugmFOLFOX-6
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
- DrugNivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
- DrugTrifluridine/tipiracil
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
- DrugBevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
- DrugFOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Locations (28)
- Honor HealthScottsdale, Arizona
- Arizona Cancer Center at University of ArizonaTucson, Arizona
- University of California, Los Angeles (UCLA)Los Angeles, California
- Stanford Cancer Institute, Stanford UniversityPalo Alto, California
- University of California San Francisco, Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Sarcoma Oncology CenterSanta Monica, California