FOG-001 in Locally Advanced or Metastatic Solid Tumors

May 26, 2026 updated by: Parabilis Medicines, 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 solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a FIH, Phase 1/2, multicenter, open-label, non-randomized, dose escalation, dose expansion, and multiple subcutaneous dose study to evaluate the safety, tolerability, PK, pharmacodynamics, and antitumor activity of FOG-001 as monotherapy and in combination with other anticancer agents in participants with advanced or metastatic solid tumors likely or known to have a Wnt pathway activating mutation (WPAM).

Study Type

Interventional

Enrollment (Estimated)

595

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

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Integrated Clinical Oncology Network (ICON)
        • Contact:
          • Vladimir Andelkovic, MD
          • Phone Number: +61755198211
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
          • Jeremy Lewin, MD
          • Phone Number: +61385595000
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Mahesh Seetharam, MD
          • Phone Number: 480-301-8000
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
          • Sunil Sharma, MD
          • Phone Number: 480-323-1350
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Arizona Cancer Center at University of Arizona
        • Contact:
          • Aaron Scott, MD
          • Phone Number: 520-694-2873
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles (UCLA)
        • Contact:
          • Randy Hecht, MD
          • Phone Number: 310-829-5471
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute, Stanford University
        • Contact:
          • Nam Bui
          • Phone Number: 650-498-6000
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco, Helen Diller Family Comprehensive Cancer Center
        • Contact:
          • Varun Monga, MD
          • Phone Number: 888-689-8273
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Center
        • Contact:
          • Sant Chawla, MD
          • Phone Number: 301-552-9999
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Breelyn Wilky, MD
          • Phone Number: 305-243-1287
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University School Of Medicine
        • Contact:
          • Michael Cecchini, MD
          • Phone Number: 415-302-7807
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Johns Hopkins University, Sibley Memorial Hospital
        • Contact:
          • Mike J Pishvaian, MD/PhD
          • Phone Number: 202-804-3343
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Conor O'Donnell, MD
          • Phone Number: 904-953-6870
      • Lake Mary, Florida, United States, 32746
        • Terminated
        • Florida Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center
        • Contact:
          • Mike J Pishvaian, MD/PhD
          • Phone Number: 410-955-8964
        • Contact:
          • Eric Christenson, MD
          • Phone Number: 410-955-8964
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Samuel Klempner, MD
          • Phone Number: 617-724-4000
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
          • Candace Haddox, MD
          • Phone Number: 617-632-3000
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center
        • Contact:
          • Ajay Prakash, MD/PhD
          • Phone Number: 612-273-8383
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Hao Xie, MD
          • Phone Number: 504-284-2511
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Moh'd Khushman, MD
          • Phone Number: 314-362-9115
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Rona Yaeger, MD
          • Phone Number: 646-888-5109
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
          • Niharika Mettu, MD
          • Phone Number: 919-681-2954
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Wen Wee Ma, MBBS
          • Phone Number: 216-444-2200
        • Contact:
          • Dale Shepard, MD, PhD
          • Phone Number: (216) 444-2200
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center
        • Contact:
          • David Bajor, MD
          • Phone Number: 216-765-9033
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Shivaani Kummar, MD
          • Phone Number: 503-494-8534
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania, Perelman School of Medicine
        • Contact:
          • Mark O'Hara, MD
          • Phone Number: 215-662-4646
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center, Hillman Cancer Center
        • Contact:
          • Dennis J Hsu, MD
          • Phone Number: 412-623-1722
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Meredith S Pelster, MD
          • Phone Number: 615-329-6862
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Ingram Cancer Center
        • Contact:
          • Kristen Ciombor, MD
          • Phone Number: 615-322-3000
    • 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
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
          • Ludimila Cavalcante, MD
          • Phone Number: 434-358-8780
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin, Carbone Cancer Center
        • Contact:
          • Jeremy Kratz, MD
          • Phone Number: 608-263-1300

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 and Part 1g):

  • 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 Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):

  • Histologically, cytologically, or radiographically confirmed HCC with a documented WPAM (by local ctDNA or tumor NGS testing) in APC or CTNNB1

Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h, and Part 2d):

  • Desmoid tumor (aggressive fibromatosis)

Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-1 and Part 2f-1) FOG-001 + FOLFOX + Bevacizumab:

  • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR CRC
  • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.
  • One dose of mFOLFOX6 with or without bevacizumab in the unresectable or metastatic setting prior to enrollment is allowed.

Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 + Nivolumab

  • Non-MSI-H or non-dMMR (by local testing) CRC with or without liver metastases.
  • MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1
  • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible

Additional Inclusion Criteria for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 + Trifluridine/Tipiracil + Bevacizumab

  • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC
  • Participants with tumors known to be negative for APC LoF mutations or CTNNB1 GoF mutations (per NGS tests) are not eligible.

Additional Inclusion Criteria for Dose Expansion Cohort (Part 2a):

  • Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC

Additional Inclusion Criteria for Dose Expansion Cohort (Part 2b):

  • Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence

Exclusion Criteria:

  • Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.
  • 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.
  • Uncontrolled inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease)
  • 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 Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1b
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1f-1
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: mFOLFOX-6
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Leucovorin, 5-fluorouracil, Oxaliplatin
Drug: Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Avastin
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: Nivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Opdivo
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1f-3
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Avastin
Drug: Trifluridine/tipiracil
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Lonsurf
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2a
MSS CRC, irrespective of WPAM status
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2b
Solid Tumors with documented WPAM
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2c
Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2e
Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2f-1
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: mFOLFOX-6
mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Leucovorin, 5-fluorouracil, Oxaliplatin
Drug: Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Avastin
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2f-2
Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: Nivolumab
Nivolumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Opdivo
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2f-3
MSS CRC (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: Bevacizumab
Bevacizumab will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Avastin
Drug: Trifluridine/tipiracil
Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001
Other Names:
  • Lonsurf
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1d-1
Desmoid Tumors
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1d-2
Desmoid Tumors
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 2d
Desmoid Tumors
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1g
Solid Tumors with documented WPAM (known WPAM negative participants are not eligible)
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days
Experimental: Part 1h
Desmoid Tumors
Drug: FOG-001
FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days
Drug: FOG-001
FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 10 months
Number and severity of treatment emergent adverse events as assessed by CTCAE v5.0
Through study completion, an average of 10 months
During dose expansion describe the Overall Response Rate using RECIST v1.1
Time Frame: Every 63 days until study completion, approximately 10 months on average
The rate of objective responses (Partial & Complete) using RECIST v1.1
Every 63 days until study completion, approximately 10 months on average
During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)
Time Frame: 4 months
The rate of objective responses (Stable, Partial, & Complete) using RECIST v1.1
4 months
During dose expansion describe the PSA30 response rate for participants with prostate cancer
Time Frame: Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)
The response to treatment as a 30% or greater reduction in PSA levels from baseline
Baseline, weekly during the first 2 cycles (56 days), bi-weekly during the Cycle 3 (28 days), and then monthly (up to approximately 7 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Maximum observed plasma concentration (Cmax) of FOG-001 and associated metabolites
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
Time to achieve Cmax (Tmax) of FOG-001 and associated metabolites in plasma
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
Area under the plasma concentration-time curve (AUC) of FOG-001 and associated metabolites
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
Plasma trough concentration (Ctrough) of FOG-001 and associated metabolites
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
Clearance (CL) of FOG-001 from the plasma
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
Volume of distribution of FOG-001
Time Frame: During first 2 cycles (56 days)
During first 2 cycles (56 days)
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
Time Frame: Every 63 days until study completion, approximately 10 months on average
Best response to treatment using RECIST v1.1
Every 63 days until study completion, approximately 10 months on average
During dose escalation and expansion to describe Duration of Response using RECIST v1.1
Time Frame: Every 63 days until study completion, approximately 10 months on average
Time from initial objective response (partial response or complete response) to disease progression
Every 63 days until study completion, approximately 10 months on average
During dose escalation and expansion describe Progression Free Survival
Time Frame: From date of randomization until the date of first disease progression, an average of 10 months
Progression Free Survival (PFS) using RECIST v1.1
From date of randomization until the date of first disease progression, an average of 10 months
During dose escalation and expansion describe the Disease Control Rate using RECIST v1.1
Time Frame: Every 63 days until study completion, approximately 10 months on average
The rate of objective responses (Stable, Partial, & Complete) using RECIST v1.1
Every 63 days until study completion, approximately 10 months on average
During dose escalation and expansion describe the Time To Progression using RECIST v1.1
Time Frame: From date of randomization until the date of first disease progression, an average of 10 months
Time To Progression (TTP) using RECIST v1.1
From date of randomization until the date of first disease progression, an average of 10 months
During dose escalation and expansion describe radiographic Progression Free Survival for participants with prostate cancer
Time Frame: From date of randomization until the date of first disease progression, an average of 10 months
Radiographic Progression Free Survival (rPFS) using PCWG3 assessment criteria
From date of randomization until the date of first disease progression, an average of 10 months
During dose escalation select the preliminary recommended Phase 2 dose and dosing schedule of study drug
Time Frame: Through Part 1 study completion
Through Part 1 study completion
Rate of DLTs across dose levels
Time Frame: During Cycle 1 (28 days)
During Cycle 1 (28 days)

Collaborators and Investigators

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

Sponsor

Parabilis Medicines, Inc.

Investigators

  • Study Chair: Jorge Ramos, DO, 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 Major Dates

Study Start (Actual)

May 23, 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)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

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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