FOG-001 in Locally Advanced or Metastatic Solid Tumors
Sponsor: Fog Pharmaceuticals, Inc.
ClinicalTrials ID:NCT05919264
This Phase 1/2 study evaluates FOG-001, a Beta-catenin inhibitor, for safety, PK/PD, and antitumor activity in advanced solid tumors. Eligible participants have ECOG 0-1 and adequate organ function. FOG-001 is given IV in 21/28-day cycles. Inclusion varies by cohort, focusing on specific cancers with WNT-pathway mutations.
Patient Parameters
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Program Overview
The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.
Description
This first-in-human, Phase 1/2, multicenter, open-label, non-randomized dose escalation and expansion study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of FOG-001 in participants with locally advanced or metastatic solid tumors. FOG-001 is a first-in-class direct inhibitor of Beta-catenin, which functions by blocking its interaction with the T-cell factor (TCF) family of transcription factors.
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):
- 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 Expansion Cohort (Cohort 2a): Colorectal Cancer (CRC) Cohort
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2b): Non-small Cell Lung Cancer (NSCLC) Cohort
- Diagnosis of treatment-refractory advanced/metastatic NSCLC with documented WPAMs in adenomatous polyposis coli (APC) or Beta-catenin.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2c): Gastric/Gastroesophageal junction (GEJ) Cohort
- Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with documented WPAMs in APC or Beta-catenin.
Additional Inclusion Criteria for Dose Expansion Cohort (Cohort 2d): Tumor Agnostic Cohort
- Diagnosis of treatment-refractory advanced/metastatic solid tumor with documented WPAMs.
Exclusion Criteria
- Known history of bone metastasis.
- 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, or a FRAX 10-year probability of hip fracture ≥3% or a 10-year probability of major osteoporosis-related fracture ≥20%, based on the US-adapted WHO algorithm for postmenopausal women and men ≥50 years of age.
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Honor Health | 85258 | Scottsdale | Arizona |
| Yale University School of Medicine | 06520 | New Haven | Connecticut |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Oregon Health and Science University | 97239 | Portland | Oregon |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
| South Texas Accelerated Research Therapeutics, LLC | 78229 | San Antonio | Texas |
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