FOG-001 in Locally Advanced or Metastatic Solid Tumors

Description

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

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Study Overview

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Study Details

Study 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.

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

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health, Scottsdale, Arizona, United States, 85258

New Haven

Yale University School of Medicine, New Haven, Connecticut, United States, 06520

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • * Adequate organ and marrow function.
  • * 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).
  • * 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.
  • * Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
  • * Diagnosis of treatment-refractory advanced/metastatic NSCLC with documented WPAMs in adenomatous polyposis coli (APC) or Beta-catenin.
  • * Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with documented WPAMs in APC or Beta-catenin.
  • * Diagnosis of treatment-refractory advanced/metastatic solid tumor with documented WPAMs.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Parabilis Medicines, Inc.,

Marie Nguyen, MD, STUDY_CHAIR, Parabilis Medicines, Inc.

Study Record Dates

2027-08-31