Clinical trial for Cancer
Official title FOG-001 in Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05919264
What this study is testing
What is FOG-001?
FOG-001 is an investigational IV medicine being studied for the treatment of advanced or metastatic solid tumors and familial adenomatous polyposis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether FOG-001 is safe and works for people with advanced solid tumors or familial adenomatous polyposis.
- Who it's for
- You may be able to join if you have a locally advanced or metastatic solid tumor, or if you have familial adenomatous polyposis.
- What's involved
- You will receive the FOG-001 treatment and have regular check‑ins to monitor safety and how well it works.
- Time commitment
- The study lasts several months and includes multiple visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Diagnosis of treatment-refractory advanced/metastatic non-MSI-H or non-dMMR CRC.
- 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.
- 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 for Dose Escalation and Dose Expansion Cohorts (Part 1f-3 and Part 2f-3): FOG-001 +...
- 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
- Diagnosis of advanced or metastatic solid tumors with a documented WPAM (by local testing) or equivalent evidence
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.