FOG-001 for Cancer

Recruiting at 8 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

480 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug FOG-001 for cancer?

The research suggests that improvements in progression-free survival (PFS) and time to progression (TTP) can be important indicators of a drug's effectiveness in controlling cancer growth, even if they don't always lead to longer overall survival. This means that if FOG-001 shows significant PFS or TTP benefits, it could be considered effective in managing cancer. ^{1 2 3 4 5}

Research Team

Marie Nguyen, MD

Principal Investigator

Parabilis Medicines, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 (documented WPAM in APC or CTNNB1 required)

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 Experimental Treatment 1 Intervention

Desmoid Tumors (documented WPAM in APC or CTNNB1 required)

Group XV: Part 1c Experimental Treatment 1 Intervention

Hepatocellular Carcinoma (documented WPAM in APC or CTNNB1 required)

Group XVI: Part 1b Experimental Treatment 1 Intervention

MSS CRC (known WPAM negative participants are not eligible)

Group XVII: 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+

Findings from Research

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 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]

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 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]

References

1. United States 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. [2022]

2. United States 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. [2022]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Inpatient utilization of immune checkpoint inhibitors and clinical outcomes. [2023]

5. United States 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. [2022]