FOG-001 in Locally Advanced or Metastatic Solid Tumors

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.