FOG-001 in Locally Advanced or Metastatic Solid Tumors

Purpose

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

Conditions

  • Cancer
  • Colorectal Cancer
  • Solid Tumor
  • Locally Advanced Solid Tumor
  • Metastatic Cancer
  • Gastric Cancer
  • Non-small Cell Lung Cancer
  • Non-small Cell Carcinoma
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • Non-Small Cell Carcinoma of Lung, TNM Stage 4
  • Gastroesophageal-junction Cancer
  • WNT Pathway
  • β-catenin
  • Beta-catenin
  • Adenomatous Polyposis Coli
  • APC

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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): - 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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1a 		Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 21 or 28 days
Experimental
Part 1b 		Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
  • Drug: FOG-001
    FOG-001 will be administered IV at assigned doses in continuous cycles of 21 or 28 days
Experimental
Cohort 2a 		Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
  • Drug: FOG-001
    FOG-001 will be administered IV once weekly at the preliminary RP2D dose in continuous cycles of 21 or 28 days
Experimental
Cohort 2b 		Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
  • Drug: FOG-001
    FOG-001 will be administered IV once weekly at the preliminary RP2D dose in continuous cycles of 21 or 28 days
Experimental
Cohort 2c 		Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
  • Drug: FOG-001
    FOG-001 will be administered IV once weekly at the preliminary RP2D dose in continuous cycles of 21 or 28 days
Experimental
Cohort 2d 		Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)
  • Drug: FOG-001
    FOG-001 will be administered IV once weekly at the preliminary RP2D dose in continuous cycles of 21 or 28 days

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Samuel Klempner, MD
617-724-4000

More Details

Status
Recruiting
Sponsor
Fog Pharmaceuticals, Inc.

Study Contact

Clinical Trial Inquiries
(857) 259-6305
clinicaltrials@fogpharma.com

Detailed 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.