FOG-001 in Locally Advanced or Metastatic Solid Tumors

Launched by PARABILIS MEDICINES, INC. · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called FOG-001, is investigating a new treatment for people with advanced or metastatic solid tumors, which are types of cancer that have spread beyond their original site. The main goal is to see if the drug FOG-001 is safe and effective for patients with specific types of cancer, including colorectal cancer, non-small cell lung cancer, and gastric cancer, especially those who have not responded to previous treatments. The trial is currently looking for participants aged 65 to 74, but anyone can apply, as long as they have a certain level of health (measured by the ECOG performance status) and their cancer meets specific criteria.

If you join this trial, you will receive FOG-001 and be monitored closely by medical professionals to track its effects and your health. You may qualify if you have advanced cancer that has not responded to other therapies and have specific genetic markers related to your cancer. However, there are some health conditions that would exclude you from participating, such as severe bone issues or certain kinds of heart problems. This trial could be an opportunity to access a new treatment option while contributing to important cancer research.

Gender

ALL

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 1e):
• • 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 that is suitable for a core needle biopsy.
• Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):
• • 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).
• Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d and Part 2d):
• • Desmoid tumor (aggressive fibromatosis) with a documented WPAM (by local testing) in APC or CTNNB1.
• Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:
• • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC
• • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
• • Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab
• • Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.
• • MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1
• • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible
• • Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab
• • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
• • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
• Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):
• • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
• Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b):
• • Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
• Exclusion Criteria:
• • 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.
• • Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently.
• • Unstable/inadequate cardiac function.
• • Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.
• • Pregnant, lactating, or planning to become pregnant.