33 Participants Needed

ZM008 Alone and With Pembrolizumab for Cancer

Recruiting at 2 trial locations
MG
JF
Overseen ByJyotsna Fuloria, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Pembrolizumab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients should have recovered from previous treatment side effects and that certain conditions, like active infections or autoimmune diseases requiring high-dose steroids, may affect eligibility. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug ZM008 when used alone or with pembrolizumab for cancer?

Pembrolizumab, when used alone, has been shown to improve survival in patients with advanced non-small-cell lung cancer and melanoma, suggesting it is effective in treating certain types of cancer.12345

What safety data exists for pembrolizumab in cancer treatment?

Pembrolizumab has been shown to have a generally favorable safety profile, with rare but serious side effects, in treating various cancers like melanoma and lung cancer. It is well-tolerated in many patients, even those who are fragile and have limited treatment options.46789

What makes the drug ZM008 unique compared to other cancer treatments?

ZM008 is being studied both alone and in combination with pembrolizumab, a drug that enhances the immune system's ability to fight cancer by targeting the PD-1 pathway. This combination could potentially offer a novel approach by leveraging pembrolizumab's known effectiveness in certain cancers, although specific details about ZM008's unique properties or mechanisms are not provided in the available research.1341011

Research Team

MG

Maloy Ghosh, PhD

Principal Investigator

Zumutor Biologics Inc.

JF

Jyotsna Fuloria

Principal Investigator

Fuloria Clinical Research Solutions LLC

Eligibility Criteria

This trial is for patients with various advanced solid tumors, like breast, lung, and prostate cancer, who have no standard treatment options left or can't tolerate them. It's not specified who can't join the trial.

Inclusion Criteria

My cancer can be measured on scans.
My kidneys are functioning well enough (CrCL ≥30 mL/min).
Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must adhere to contraceptive requirements
See 8 more

Exclusion Criteria

I have not received any live vaccines in the last 30 days.
I have an autoimmune disease treated with drugs that affect my immune system.
I have had lung inflammation or scarring before.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dose escalation of ZM008 as a single agent followed by combination with Pembrolizumab

Up to 36 months
Visits every 21 days for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

  • ZM008
Trial OverviewThe study tests ZM008 alone and combined with Pembrolizumab to find safe doses in people whose cancers haven't responded to typical treatments. It's an early-stage (phase 1) dose-finding study.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
Dose escalation of ZM008.

ZM008 is already approved in United States for the following indications:

🇺🇸
Approved in United States as ZM008 for:

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    Who Is Running the Clinical Trial?

    Zumutor Biologics Inc.

    Lead Sponsor

    Trials
    1
    Recruited
    30+

    Findings from Research

    Pembrolizumab (PEM) significantly improved short-term treatment effectiveness and long-term survival rates in patients with advanced cutaneous malignant melanoma compared to chemotherapy with Temozolomide, with a notable increase in one-year survival rates (53.85% vs. 40.00%).
    The use of PEM did not lead to a higher incidence of adverse reactions compared to the control group, indicating that it is a relatively safe treatment option for patients with this type of melanoma.
    Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma.Fu, L., Zhang, H., Jiang, J., et al.[2021]
    In the KEYNOTE-024 study involving 305 patients with untreated advanced non-small-cell lung cancer, pembrolizumab significantly improved overall survival (OS) compared to platinum-based chemotherapy, with a median OS of 30.0 months versus 14.2 months for chemotherapy.
    Pembrolizumab also had a better safety profile, with fewer treatment-related severe adverse events (31.2% for pembrolizumab vs. 53.3% for chemotherapy), indicating it is a safer option for patients.
    Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater.Reck, M., Rodríguez-Abreu, D., Robinson, AG., et al.[2022]
    In a study of 100 patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab, further stratification of PD-L1 tumor proportion score (TPS) beyond 50% did not significantly affect progression-free survival (PFS).
    Smoking status was associated with improved PFS, while prior radiotherapy was linked to decreased PFS, indicating that these factors, along with performance status, may serve as important biomarkers for predicting response to pembrolizumab treatment.
    Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study.Mander, ES., Merrick, CB., Nicholson, HA., et al.[2023]

    References

    Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma. [2021]
    Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. [2022]
    Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]
    Evaluation of efficacy and safety of different pembrolizumab dose/schedules in treatment of non-small-cell lung cancer and melanoma: a systematic review. [2018]
    Clinical performance of endobronchial ultrasound-guided transbronchial needle aspiration for assessing programmed death ligand-1 expression in nonsmall cell lung cancer. [2018]
    Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]
    Clinical utility of pembrolizumab in the management of advanced solid tumors: an evidence-based review on the emerging new data. [2023]
    Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. [2023]
    Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
    10.United Statespubmed.ncbi.nlm.nih.gov
    Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. [2022]
    Pembrolizumab in lung cancer: current evidence and future perspectives. [2020]