Mass General - Division of Clinical Research

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

Arm	Description	Assigned 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.