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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 months
Awards & highlights
Study Summary
This trial will test a new drug to see if it's safe and effective for people with advanced or spread cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Area under the plasma concentration-time curve (AUC) of FOG-001
Clearance (CL) of FOG-001 from the plasma
During dose escalation Part 1b to evaluate the pharmacodynamic activity in tumors
+7 moreTrial 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)
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Who is running the clinical trial?
Fog Pharmaceuticals, Inc.Lead Sponsor
Keith Orford, MD, PhDStudy ChairFog Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active inflammatory bowel disease or need treatment for it now.My cancer has spread to my bones.I have complications like brain metastases or spinal issues related to my cancer.My organs and bone marrow are working well.My colorectal cancer is advanced, has spread, and doesn't respond to treatment.My advanced cancer does not respond to treatment and has specific genetic markers.I have had a spinal compression or a bone fracture without injury in the last year.My colorectal cancer is advanced, not responding to treatment, and can be biopsied.My advanced stomach cancer is not responding to treatment and has specific genetic changes.My heart does not function properly.I have osteoporosis with a T-score below -2.0.I am fully active or can carry out light work.My advanced lung cancer is not responding to treatment and has specific genetic changes.My advanced cancer is not responding to treatment and does not have specific genetic features.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2b
- Group 2: Cohort 2c
- Group 3: Cohort 2d
- Group 4: Part 1b
- Group 5: Cohort 2a
- Group 6: Part 1a
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation have open enrollment at present?
"Affirmative, the information on clinicialtrials.gov alludes to this trial being in a state of recruitment. This research was first launched on May 19th 2023 and last updated June 21st 2023. The study is seeking 208 individuals from one medical facility."
Answered by AI
What are the main goals of this clinical trial?
"This clinical trial's primary purpose is to gauge dose-limiting toxicities over a four month time period. Secondary goals consist of determining the optimal dosage and dosing schedule, measuring pharmacodynamic activity in tumors via Myc expression changes, and evaluating Best Overall Response Rate using RECIST v1.1 criteria."
Answered by AI
How many individuals are taking part in this experiment?
"Affirmative. Clinicaltrials.gov has confirmed that this medical trial, first advertised on May 19th 2023 is actively recruiting participants. 208 patients must be registered from a single centre in order to fulfil the recruitment requirements of the study."
Answered by AI
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