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RecruitingPhase 1 / Phase 2

FOG-001 in Locally Advanced or Metastatic Solid Tumors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether FOG-001 is safe and works against solid tumors that have grown into nearby tissue or spread to other parts of the body. It also includes people with familial adenomatous polyposis (FAP), a condition that causes many growths called polyps in the gut. Some groups receive FOG-001 with other cancer drugs.

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 or in participants with familial adenomatous polyposis (FAP).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be fully active or able to walk and do light work. Your organs and bone marrow, which makes blood cells, must work well enough.
  • Each study group has different rules. Several groups require advanced colon or rectal cancer with certain DNA repair test results, called non-MSI-H or non-dMMR. Some require cancer that no longer responds to treatment.
  • Some solid tumor groups require gene changes that turn on a cell signal called WNT, or similar test evidence. Part 1b also requires a tumor that can be sampled with a core needle.
  • The liver cancer groups require confirmed hepatocellular carcinoma and an APC or CTNNB1 gene change that turns on WNT. Other groups require a desmoid tumor, a growth also called aggressive fibromatosis.
  • The FOLFOX plus bevacizumab and trifluridine/tipiracil plus bevacizumab groups require advanced non-MSI-H or non-dMMR colon or rectal cancer. The FOLFOX group allows one prior dose of mFOLFOX6, with or without bevacizumab, for cancer that cannot be removed or has spread.
  • The nivolumab groups include non-MSI-H or non-dMMR colon or rectal cancer, with or without spread to the liver. They also include MSI-H colon or rectal cancer or solid tumors with WNT-activating changes that resist anti-PD-1/PD-L1 treatment.
  • The three combination-treatment groups do not allow tumors known to lack the specified APC or CTNNB1 gene changes.
  • The FAP group requires classic FAP with an APC gene change, colon removal more than 6 months before the first dose, and measurable polyps in the first part of the small intestine.

Who can't join

  • Cancer that has spread to bone, except prostate cancer that has spread and resists hormone-lowering treatment. People with FAP may have osteomas, which are noncancerous bone growths.
  • A crushed spine bone or a bone broken without an injury in the past 12 months, if you are not taking medicine to slow bone loss.
  • Osteoporosis, or weak bones, with a bone scan T-score of -2.5 or lower at the listed spine or hip sites.
  • Uncontrolled bowel inflammation, such as Crohn’s disease or ulcerative colitis.
  • Heart function that is unstable or not good enough.
  • Cancer in the tissue covering the brain or spinal cord, pressure on the spinal cord, or cancer in the brain that causes symptoms or is unstable.
  • Being pregnant, breastfeeding, or planning to become pregnant.
  • Removal of the entire colon within 6 months before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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. Monotherapy Dose Optimization (Part 1i): FAP * Diagnosis of phenotypic classical FAP with a documented APC mutation * Post-colectomy \>6 months prior to first dose of study drug administration with measurable duodenal polyp burden 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. For participants with FAP, osteomas are allowed. * 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. * Complete colectomy within 6 months of the first dose of study drug administration.

Study sites (31)

AZ

CA

CO

CT

DC

FL

MA

MD

MN

MO

NC

NY

OH

OR

PA

TN

TX

VA

WI