FOG-001 in Locally Advanced or Metastatic Solid Tumors

March 19, 2024 updated by: Fog Pharmaceuticals, Inc.

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
          • Sunil Sharma, MD
          • Phone Number: 480-323-1350
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University School of Medicine
        • Contact:
          • Michael Cecchini, MD
          • Phone Number: 415-302-7807
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Samuel Klempner, MD
          • Phone Number: 617-724-4000
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Moh'd Khushman, MD
          • Phone Number: 314-362-9115
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Shivaani Kummar, MD
          • Phone Number: 503-494-8534
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Meredith S Pelster, MD
          • Phone Number: 615-329-6862
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Jordi Rodon Ahnert, MD/PhD
          • Phone Number: 713-792-5603
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics, LLC
        • Contact:
          • Kyriakos Papadopoulos, MD
          • Phone Number: 210-593-5255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Osteoporosis, which is defined as a T-score of <-2.0 at the lumbar spine (L1 - L4), left (or right) femoral neck, and 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 once weekly at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 28 days
Experimental: Part 1b
Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
Drug: FOG-001
FOG-001 will be administered IV once weekly at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 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 assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 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 assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 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 assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 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 assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered IV once weekly at the RP2D dose in continuous cycles of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0
Time Frame: Through study completion, an average of 4 months
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
Through study completion, an average of 4 months
During dose escalation characterize dose-limiting toxicities (DLTs)
Time Frame: 1 treatment cycle (28 days)
Incidence of DLTs
1 treatment cycle (28 days)
During dose expansion describe the Overall Response Rate using RECIST v1.1
Time Frame: Every 56 days until study completion, approximately 4 months on average
The rate of objective responses (Partial & Complete) using RECIST v1.1
Every 56 days until study completion, approximately 4 months on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
During dose escalation select the recommended Phase 2 dose and dosing schedule of study drug
Time Frame: During Cycle 1 (28 days)
Rate of Dose Limiting Toxicities (DLTs) across dose levels
During Cycle 1 (28 days)
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
Time Frame: During first 2 cycles (56 days)
Change in tumor Myc expression (on-study compared to baseline)
During first 2 cycles (56 days)
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
Time Frame: Every 56 days until study completion, approximately 4 months on average
Best response to treatment using RECIST v1.1
Every 56 days until study completion, approximately 4 months on average
During dose escalation and expansion to describe Duration of Response using RECIST v1.1
Time Frame: Every 56 days until study completion, approximately 4 months on average
Time from initial objective response (partial response or complete response) to disease progression
Every 56 days until study completion, approximately 4 months on average
During dose expansion describe Progression Free Survival
Time Frame: From date of randomization until the date of first disease progression, an average of 4 months
Progression Free Survival (PFS) using RECIST v1.1
From date of randomization until the date of first disease progression, an average of 4 months
Plasma concentration (Cmax) of FOG-001
Time Frame: During first 2 cycle (56 days)
During first 2 cycle (56 days)
Time to achieve Cmax (Tmax) of FOG-001 in plasma
Time Frame: During first 2 cycle (56 days)
During first 2 cycle (56 days)
Area under the plasma concentration-time curve (AUC) of FOG-001
Time Frame: During first 2 cycle (56 days)
During first 2 cycle (56 days)
Clearance (CL) of FOG-001 from the plasma
Time Frame: During first 2 cycle (56 days)
During first 2 cycle (56 days)
Terminal half-life (t1/2) of FOG-001 in plasma
Time Frame: During first 2 cycle (56 days)
During first 2 cycle (56 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fog Pharmaceuticals, Inc.

Investigators

  • Study Chair: Keith Orford, MD, PhD, Fog Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOG-001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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