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New treatment option 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 medicine, given as an injection under the skin, being studied as a potential treatment for cancer.
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
- 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.
- 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.
- Adequate organ and marrow function. Additional 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...
- 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 for Dose Escalation and Dose Expansion Cohorts (Part 1c and Part 2c):
You likely can't join if
- Known history of bone metastasis. Bone metastasis are allowed for patients with mCRPC.
- 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.
- Adequate organ and marrow function. Additional 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 for...
- 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 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 for Dose Escalation and Dose Expansion Cohorts (Part 1d, Part 1h...
- Desmoid tumor (aggressive fibromatosis) Additional 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 for Dose Escalation and Dose Expansion Cohorts (Part 1f-2 and Part 2f-2): FOG-001 +...
- 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. Additional for Dose Expansion Cohort (Part 2a):
- Diagnosis of locally advanced or metastatic non-MSI-H or non-dMMR (by local testing) CRC Additional for Dose Expansion Cohort (Part 2b):
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Lake Mary, 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
+ 10 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 - 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?
Study sites include 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 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.