Image

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting
18 years of age
Both
Phase 1/2

Powered by AI

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.

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.

Eligibility

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 details

Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor, Metastatic Cancer

NCT05919264

Fog Pharmaceuticals, Inc.

14 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.