FOG-001 for Cancer

Recruiting at 18 trial locations

Overseen By Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Fog Pharmaceuticals, Inc.

Disqualifiers: Bone metastasis, Osteoporosis, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

575 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, FOG-001, is safe and effective for individuals with certain advanced or metastatic cancers. It includes several groups, testing FOG-001 alone or with other drugs on different cancers, such as colorectal cancer and desmoid tumors. Individuals with locally advanced or metastatic cancer, particularly if previous treatments failed and specific gene mutations are present, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the FOG-001 cancer trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that FOG-001 is being tested for safety and effectiveness in people with advanced or spreading cancer. In early studies, doctors have administered this treatment to patients with various solid tumors. These studies help determine how well patients tolerate the treatment and identify potential side effects.

Detailed information about specific side effects or their frequency is not yet available. As the trial is in its early stages, researchers continue to collect data on its safety in humans, closely observing how different individuals react to FOG-001.

For those considering joining the trial, it's important to understand that early trials often focus on assessing the treatment's safety. Participants will be closely monitored for any side effects to ensure their safety throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about FOG-001 because it targets the WNT-Pathway Activating Mutations (WPAM), which is a different approach from most standard cancer treatments like chemotherapy and radiation. These traditional treatments often attack rapidly dividing cells indiscriminately, but FOG-001 is designed to specifically disrupt the signaling pathways that cancer cells use to grow and spread, potentially leading to more precise and effective treatment with fewer side effects. Additionally, FOG-001 is being tested across various cancers, including hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and colorectal cancer with microsatellite stability, which highlights its potential versatility and impact across different cancer types. This targeted approach could offer new hope for patients with these challenging conditions.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that FOG-001, the investigational treatment in this trial, holds promise for treating various cancers. In liver cancer, studies found that FOG-001 can block certain pathways, leading to tumor shrinkage. In a type of colon cancer, FOG-001 controlled the disease in 50% of cases and proved even more effective when combined with other treatments like 5-FU and bevacizumab. For tumors with a specific genetic mutation, FOG-001 reduced tumor size by at least 30% in some cases. In desmoid tumors, FOG-001 led to complete tumor reduction in all cases, with an 80% response rate. These findings suggest FOG-001 could be effective for different types of cancer, and this trial will explore its effects across various treatment arms, including those for hepatocellular carcinoma, MSS colorectal cancer, and desmoid tumors. ^{1 6 7 8 9}

Who Is on the Research Team?

Jorge Ramos, DO

Principal Investigator

Parabilis Medicines, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of FOG-001 to evaluate safety, tolerability, and dose-limiting toxicities

1 cycle (28 days)

Weekly visits during the first cycle

Dose Expansion

Participants receive FOG-001 to further evaluate safety and efficacy, including disease control rate and overall response rate

10 months

Bi-weekly visits during the third cycle, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• FOG-001

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2f-3 Experimental Treatment 3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group II: Part 2f-2 Experimental Treatment 2 Interventions

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

Group III: Part 2f-1 Experimental Treatment 3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group IV: Part 2e Experimental Treatment 1 Intervention

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

Group V: Part 2d Experimental Treatment 1 Intervention

Desmoid Tumors

Group VI: Part 2c Experimental Treatment 1 Intervention

Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

Group VII: Part 2b Experimental Treatment 1 Intervention

Solid Tumors with documented WPAM

Group VIII: Part 2a Experimental Treatment 1 Intervention

MSS CRC, irrespective of WPAM status

Group IX: Part 1f-3 Experimental Treatment 3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group X: Part 1f-2 Experimental Treatment 2 Interventions

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

Group XI: Part 1f-1 Experimental Treatment 3 Interventions

MSS CRC (known WPAM negative participants are not eligible)

Group XII: Part 1e-2 Experimental Treatment 1 Intervention

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

Group XIII: Part 1e-1 Experimental Treatment 1 Intervention

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

Group XIV: Part 1d-2 Experimental Treatment 1 Intervention

Desmoid Tumors

Group XV: Part 1d-1 Experimental Treatment 1 Intervention

Desmoid Tumors

Group XVI: Part 1c Experimental Treatment 1 Intervention

Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

Group XVII: Part 1b Experimental Treatment 1 Intervention

MSS CRC (known WPAM negative participants are not eligible)

Group XVIII: Part 1a Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Fog Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

480+

Parabilis Medicines, Inc.

Lead Sponsor

Trials

1

Recruited

480+

Published Research Related to This Trial

Overall survival (OS) is the traditional measure of clinical benefit for cancer drugs, but it requires large studies and long follow-up times, making it less practical for assessing new treatments quickly.

Progression-free survival (PFS) and time to progression (TTP) are valuable alternative endpoints that directly measure the effects of treatments on cancer growth, and their improvement can indicate clinical benefit, potentially speeding up the development and availability of effective cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall survival: a gold standard in search of a surrogate: the value of progression-free survival and time to progression as end points of drug efficacy. Zhuang, SH., Xiu, L., Elsayed, YA.[2022]

In a study of 65 patients with various cancers treated with PD1-targeting antibodies, specific immune-related gene expressions were identified that correlated with better responses to treatment and longer progression-free survival (PFS).

The findings suggest that measuring preexisting immune responses through mRNA expression patterns can reliably predict clinical outcomes in patients receiving PD1 therapy, regardless of cancer type or the specific antibody used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Gene Expression Profiling After PD-1 Blockade in Non-Small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, and Melanoma. Prat, A., Navarro, A., Paré, L., et al.[2022]

In a study analyzing 78 arms from 54 lung cancer trials involving 13,438 patients, immune-related progression-free survival (iPFS) showed a strong correlation with overall survival (OS), indicating it is a better surrogate endpoint than conventional progression-free survival (cPFS).

The correlation between treatment effects on OS and iPFS was excellent (RWLS2 = 0.91), while the correlation with cPFS was moderate (RWLS2 = 0.38), suggesting that iPFS is more reliable for evaluating the effectiveness of immune-checkpoint inhibitors in lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progression-free survival assessed per immune-related or conventional response criteria, which is the better surrogate endpoint for overall survival in trials of immune-checkpoint inhibitors in lung cancer: A systematic review and meta-analysis. Zhu, GL., Yang, KB., Tang, SQ., et al.[2022]

In a study of 52 hospitalized cancer patients treated with immune checkpoint inhibitors, 68.2% either died or were admitted to hospice within 90 days, indicating a high rate of poor outcomes in this population.

Patients who had not previously received immune checkpoint inhibitors before hospitalization had a significantly shorter time to death or hospice (29 days) compared to those who had prior treatment (242 days), suggesting that prior exposure to these therapies may influence survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient utilization of immune checkpoint inhibitors and clinical outcomes. Wang, J., Lee, CS., Attarian, S., et al.[2023]

In a comprehensive analysis of 40 randomized trials, a strong correlation was found between progression-free survival (PFS) and overall survival (OS) in patients receiving PD-1/PD-L1 immune checkpoint blockade therapy, suggesting that improvements in PFS can indicate better OS outcomes.

Despite the correlation, the study highlights that modest improvements in RECIST-based endpoints like PFS and objective response rate (ORR) do not always reflect significant OS benefits, indicating that these measures are not perfect surrogates for assessing the clinical effectiveness of immune checkpoint inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Progression-Free Survival, Objective Response Rate, and Overall Survival in Clinical Trials of PD-1/PD-L1 Immune Checkpoint Blockade: A Meta-Analysis. Ye, J., Ji, X., Dennis, PA., et al.[2021]

Citations

1. parabilismed.com parabilismed.com/press-release/parabilis-medicines-presents-clinical-data-demonstrating-first-ever-drugging-of-key-cancer-driver-with-fog-001/

Parabilis Medicines Presents Clinical Data Demonstrating ... With FOG-001, Parabilis has achieved what decades of cancer research could not: directly drugging the “undruggable” β-catenin:TCF interaction.

2. trial.medpath.com trial.medpath.com/news/db66b8d7b5a9dbff/parabilis-medicines-achieves-first-ever-clinical-success-targeting-undruggable-b-catenin-tcf-interaction-with-fog-001

Parabilis Medicines Achieves First-Ever Clinical Success ... Phase 1/2 clinical trial data shows FOG-001 achieved 100% tumor reduction in desmoid patients with an 80% objective response rate, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer. Detailed ...

4. fidelity.com fidelity.com/news/article/default/202510241000BIZWIRE_USPR_____20251024_BW425471

Parabilis Medicines Presents Clinical and Preclinical Data ... FOG-001, the first and only direct β-catenin:TCF inhibitor, shows early clinical activity in a range of Wnt/β-catenin–driven tumors ...

5. merckgroup.com merckgroup.com/en/news/ogsiveo-jco-publication-21-10-2025.html

Merck Announces Publication of Long-Term Efficacy and ... Although desmoid tumors do not metastasize, they can be associated with recurrence rates of up to 77% after surgical resection.6,9 Desmoid tumor ...

6. trials.braintumor.org trials.braintumor.org/trials/NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors Study Purpose. The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.

8. delta.larvol.com delta.larvol.com/Products/?ProductId=34d9872b-ea10-49e0-8346-59c4000540e6

FOG-001 / Parabilis Medicines Parabilis Medicines Presents Clinical Data Demonstrating First-Ever Drugging of Key Cancer Driver with FOG-001 (Businesswire) - "Oral presentation at ESMO ...

9. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0291.html

Phase 1/2 study of FOG-001 in participants with locally ... The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic cancer.