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Monoclonal Antibodies

ZM008 Alone and With Pembrolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Zumutor Biologics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function: Estimated creatinine clearance (CrCL) ≥30 mL/minute

Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on computed tomography (CT), positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) scan

Must not have

Live vaccines reception within 30 days of enrollment

History of pneumonitis/interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at study completion in upto 36 months.

Awards & highlights

Summary

This trial is testing a new drug called ZM008 in patients with advanced solid tumors who have already tried standard treatments or cannot tolerate them. The drug will be given alone at first and then in combination

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since it's a phase 1 trial of ZM008, specific side effects aren’t listed but may include typical reactions to new cancer drugs such as fatigue, nausea, and immune-related responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys are functioning well enough (CrCL ≥30 mL/min).

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My cancer can be measured on scans.

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I am over 18 years old.

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My cancer has specific mutations and I've tried all suitable targeted treatments without success or cannot take them due to health reasons.

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I am fully active or can carry out light work.

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My blood counts meet the required levels for treatment.

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My cancer is advanced and cannot be cured with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received any live vaccines in the last 30 days.

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I have had lung inflammation or scarring before.

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I have a serious health condition that is not under control.

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I do not have major heart problems.

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I stopped previous immunotherapy due to side effects.

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I have brain metastasis that is not currently under control.

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I am not currently on antibiotics for an infection.

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I have another type of cancer that is currently active.

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I have an autoimmune disease treated with drugs that affect my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at study completion in upto 36 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at study completion in upto 36 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at study completion in upto 36 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Heart Rate

Change in systolic and diastolic BP

Changes in Temperature measurements.

+1 more

Secondary outcome measures

Area Under the Plasma Concentration Versus Time Curve (AUC) of the biological product ZM008

Disease Control Rate

Immune Disease Control Rate

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

Dose escalation of ZM008.

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zumutor Biologics Inc.Lead Sponsor

Jyotsna FuloriaStudy DirectorFuloria Clinical Research Solutions LLC

Maloy Ghosh, PhDStudy ChairZumutor Biologics Inc.

~22 spots leftby Dec 2026

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