What is the mechanism of action of this treatment?

Adenomatous Polyposis is commonly treated with medications that target the APC gene pathway, which is crucial in polyp formation. NSAIDs like sulindac inhibit cyclooxygenase enzymes, reducing polyp growth, while COX-2 inhibitors like celecoxib specifically target the COX-2 enzyme involved in inflammation. Chemopreventive agents like aspirin are also used for their anti-inflammatory effects. These treatments are important for patients as they directly address the genetic and molecular causes of polyp formation, potentially lowering the risk of colorectal cancer.

What side effects are associated with this type of intervention?

Common treatments for Adenomatous Polyposis, such as NSAIDs and COX-2 inhibitors, often have side effects including gastrointestinal issues like ulcers and bleeding, cardiovascular risks, and renal impairment. Chemopreventive agents may also cause gastrointestinal discomfort, liver enzyme abnormalities, and hypersensitivity reactions. It is important to monitor these side effects closely and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Adenomatous Polyposis, including nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib, which inhibits cyclooxygenase-2 (COX-2) to reduce polyp formation. Additionally, sulindac, another NSAID, has been used off-label for this condition. These treatments focus on reducing the number and size of polyps in patients with familial adenomatous polyposis (FAP). While the mechanism of action for FOG-001 is not specified, it is important to discuss with a healthcare provider how it compares to these existing therapies.

What other types of research exist?

Promising novel alternatives for Adenomatous Polyposis patients in 2024 may include selective RET inhibitors like selpercatinib and pralsetinib, which have shown efficacy in RET-altered cancers. Additionally, PI3K inhibitors such as copanlisib, which have been studied in lymphomas, may offer potential due to their mechanism of action targeting cellular growth pathways. These treatments represent advancements in targeted therapy that could be relevant for managing Adenomatous Polyposis.

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FOG-001 for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Fog Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC (for Dose Expansion Cohort - Colorectal Cancer (CRC) Cohort)

Diagnosis of treatment-refractory advanced/metastatic gastric/GEJ cancer with documented WPAMs in APC or Beta-catenin (for Dose Expansion Cohort - Gastric/Gastroesophageal junction (GEJ) Cohort)

Must not have

Inflammatory bowel disease (i.e., ulcerative colitis or Crohn's disease) that is recently active or requires therapy currently

Known history of bone metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing FOG-001, a new medicine, to see if it is safe and effective for patients with advanced or spreading solid tumors. FOG-001 works by blocking certain proteins to stop cancer cells from growing.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that are resistant to treatment, including specific types of lung, colorectal, and stomach cancers. Participants must have certain genetic mutations related to cancer growth, be in good physical condition (ECOG 0-1), and have functioning organs and bone marrow.

What is being tested?

FOG-001 is the focus of this study. Researchers want to see if it's safe and works against various advanced cancers that haven't responded to other treatments. The trial involves different stages where doses are adjusted based on patient responses.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions seen with cancer therapies such as fatigue, nausea, organ inflammation due to immune response, blood count changes increasing infection risk, and possible impact on bone health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colorectal cancer is advanced, has spread, and doesn't respond to treatment.

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My advanced stomach cancer is not responding to treatment and has specific genetic changes.

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I am fully active or can carry out light work.

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My advanced lung cancer is not responding to treatment and has specific genetic changes.

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My advanced cancer is not responding to treatment and does not have specific genetic features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active inflammatory bowel disease or need treatment for it now.

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My cancer has spread to my bones.

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I have complications like brain metastases or spinal issues related to my cancer.

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I have had a spinal compression or a bone fracture without injury in the last year.

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My heart does not function properly.

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I have osteoporosis with a T-score below -2.0.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

During dose escalation and dose expansion measure incidence and severity of treatment emergent adverse events by CTCAE v5.0

During dose escalation characterize dose-limiting toxicities (DLTs)

During dose expansion describe the Disease Control Rate using RECIST v1.1 (Part 2a only)

+2 more

Secondary study objectives

During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors

During dose escalation and expansion describe Progression Free Survival

During dose escalation and expansion describe radiographic Progression Free Survival for participants with prostate cancer

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

17Treatment groups

Experimental Treatment

Group I: Part 2f-3Experimental Treatment3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group II: Part 2f-2Experimental Treatment2 Interventions

Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)

Group III: Part 2f-1Experimental Treatment3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group IV: Part 2eExperimental Treatment1 Intervention

Metastatic Castration-Resistant Prostate Cancer (documented WPAM in APC or CTNNB1 required)

Group V: Part 2dExperimental Treatment1 Intervention

Desmoid Tumors (documented WPAM in APC or CTNNB1 required)

Group VI: Part 2cExperimental Treatment1 Intervention

Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

Group VII: Part 2bExperimental Treatment1 Intervention

Solid Tumors with documented WPAM

Group VIII: Part 2aExperimental Treatment1 Intervention

MSS CRC, irrespective of WPAM status

Group IX: Part 1f-3Experimental Treatment3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group X: Part 1f-2Experimental Treatment2 Interventions

Solid Tumors with documented WPAM or MSS CRC (known WPAM negative participants are not eligible)

Group XI: Part 1f-1Experimental Treatment3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group XII: Part 1e-2Experimental Treatment1 Intervention

Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status

Group XIII: Part 1e-1Experimental Treatment1 Intervention

Solid Tumors with documented WPAM or MSS CRC, irrespective of WPAM status

Group XIV: Part 1dExperimental Treatment1 Intervention

Desmoid Tumors (documented WPAM in APC or CTNNB1 required)

Group XV: Part 1cExperimental Treatment1 Intervention

Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

Group XVI: Part 1bExperimental Treatment1 Intervention

MSS CRC (known WPAM negative participants are not eligible)

Group XVII: Part 1aExperimental Treatment1 Intervention

Solid Tumors with any WNT-Pathway Activating Mutation (WPAM) or Microsatellite Stable (MSS) Colorectal Cancer (CRC), irrespective of WPAM status

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

mFOLFOX-6

2010

Completed Phase 2

~160

Nivolumab

2015

Completed Phase 3

~4010

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adenomatous Polyposis is commonly treated with medications that target the APC gene pathway, which is crucial in polyp formation. NSAIDs like sulindac inhibit cyclooxygenase enzymes, reducing polyp growth, while COX-2 inhibitors like celecoxib specifically target the COX-2 enzyme involved in inflammation. Chemopreventive agents like aspirin are also used for their anti-inflammatory effects. These treatments are important for patients as they directly address the genetic and molecular causes of polyp formation, potentially lowering the risk of colorectal cancer.

Feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy.Medical Treatment for Microscopic Colitis: A Community Hospital's Experience.[Impact of spasmolytic on polyp and adenoma detection during colonoscopy: a meta-analysis].