← Back to Search

Other

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 4 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
Select...
My colorectal cancer is advanced, has spread, and doesn't respond to treatment.
Select...
My advanced stomach cancer is not responding to treatment and has specific genetic changes.
Select...
I am fully active or can carry out light work.
Select...
My advanced lung cancer is not responding to treatment and has specific genetic changes.
Select...
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:
Select...
I have active inflammatory bowel disease or need treatment for it now.
Select...
My cancer has spread to my bones.
Select...
I have complications like brain metastases or spinal issues related to my cancer.
Select...
I have had a spinal compression or a bone fracture without injury in the last year.
Select...
My heart does not function properly.
Select...
I have osteoporosis with a T-score below -2.0.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 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 Overall Response Rate using RECIST v1.1
Secondary study objectives
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
During dose escalation and expansion to describe Best Overall Response Rate using RECIST v1.1
During dose escalation and expansion to describe Duration of Response using RECIST v1.1
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part 1bExperimental Treatment1 Intervention
Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)
Group II: Part 1aExperimental Treatment1 Intervention
Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs) or Microsatellite Stable (MSS) Colorectal Cancer (Irrespective of WPAM Status)
Group III: Cohort 2dExperimental Treatment1 Intervention
Solid Tumors with Any WNT-Pathway Activating Mutations (WPAMs)
Group IV: Cohort 2cExperimental Treatment1 Intervention
Gastric Cancer/Gastroesophageal Junction Carcinoma (GEJ) with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
Group V: Cohort 2bExperimental Treatment1 Intervention
Non-Small Cell Lung Cancer with a WNT-Pathway Activating Mutation (WPAM) in Adenomatous Polyposis Coli (APC) or Beta-Catenin
Group VI: Cohort 2aExperimental Treatment1 Intervention
Microsatellite Stable Colorectal Cancer (Irrespective of WPAM Status)

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].

Find a Location

Who is running the clinical trial?

Fog Pharmaceuticals, Inc.Lead Sponsor
Keith Orford, MD, PhDStudy ChairFog Pharmaceuticals, Inc.
Marie Nguyen, MDStudy ChairFog Pharmaceuticals, Inc.
4 Previous Clinical Trials
401 Total Patients Enrolled

Media Library

FOG-001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05919264 — Phase 1 & 2
Non-Small Cell Carcinoma Research Study Groups: Cohort 2b, Cohort 2c, Cohort 2d, Part 1b, Cohort 2a, Part 1a
Non-Small Cell Carcinoma Clinical Trial 2023: FOG-001 Highlights & Side Effects. Trial Name: NCT05919264 — Phase 1 & 2
FOG-001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919264 — Phase 1 & 2
~154 spots leftby Apr 2027