RECRUITING

FOG-001 in Locally Advanced or Metastatic Solid Tumors

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Conditions

CancerColorectal CancerSolid TumorLocally Advanced Solid TumorMetastatic CancerGastric CancerNon-small Cell Lung CancerNon-small Cell CarcinomaNon-small Cell Lung Cancer MetastaticNon-small Cell Lung Cancer Stage IIIBNon-Small Cell Carcinoma of Lung, TNM Stage 4Gastroesophageal-junction CancerWNT Pathwayβ-cateninBeta-cateninAdenomatous Polyposis ColiAPCWNT Pathway Activating Mutation (WPAM)Non-small Cell Lung Cancer (NSCLC)Gastric Cancer (GC)Gastroesophageal-junction Cancer (GEJ)Colorectal Cancer (CRC)Microsatellite Stable (MSS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-05-23
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05919264

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  2. * Adequate organ and marrow function.
  3. * 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).
  4. * Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
  5. * At least one lesion that is suitable for a core needle biopsy.
  6. * Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
  7. * Diagnosis of treatment-refractory advanced/metastatic NSCLC with documented WPAMs in adenomatous polyposis coli (APC) or Beta-catenin.
  8. * Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with documented WPAMs in APC or Beta-catenin.
  9. * Diagnosis of treatment-refractory advanced/metastatic solid tumor with documented WPAMs.
  1. * Known history of bone metastasis.
  2. * Evidence of vertebral compression fracture or non-traumatic bone fracture within the past 12 months and who are not receiving antiresorptive therapy.
  3. * 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.
  4. * Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently.
  5. * Unstable/inadequate cardiac function.
  6. * Has known meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases.
  7. * Pregnant, lactating, or planning to become pregnant.

Contacts and Locations

Study Contact

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

Principal Investigator

Marie Nguyen, MD
STUDY_CHAIR
Parabilis Medicines, Inc.

Study Locations (Sites)

Honor Health
Scottsdale, Arizona, 85258
United States
Yale University School of Medicine
New Haven, Connecticut, 06520
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Parabilis Medicines, Inc.

  • Marie Nguyen, MD, STUDY_CHAIR, Parabilis Medicines, 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 Registration Dates

Study Start Date2023-05-23
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-05-23
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Cancer
  • Colorectal Cancer
  • Solid Tumor
  • Locally Advanced Solid Tumor
  • Metastatic Cancer
  • WNT Pathway Activating Mutation (WPAM)
  • Non-small Cell Lung Cancer (NSCLC)
  • Gastric Cancer (GC)
  • Gastroesophageal-junction Cancer (GEJ)
  • Colorectal Cancer (CRC)
  • Microsatellite Stable (MSS)

Additional Relevant MeSH Terms

  • 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