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Monoclonal Antibodies

ZB131 for Solid Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by ZielBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial is testing a new drug, ZB131, to see if it is safe and effective in treating solid tumors. Up to 24 patients will be enrolled, and the drug will be given via IV every week.

Who is the study for?
Adults over 18 with advanced solid tumors, including specific types of pancreatic, ovarian, and biliary cancers that have not responded to standard treatments. Participants must be in relatively good health (ECOG status 0-1), have a life expectancy of at least 3 months, measurable disease per RECIST criteria, and agree to provide tissue samples. They should also have adequate organ function and not be pregnant or breastfeeding. Effective contraception is required for participants of childbearing potential.Check my eligibility
What is being tested?
The trial is testing ZB131, an investigational drug given via IV weekly to treat various solid tumors with high CSP expression. The study includes a dose escalation stage to determine the safest and most effective dosage followed by an expansion at the recommended phase two dose (RP2D). Treatment continues until disease progression or unacceptable side effects occur.See study design
What are the potential side effects?
While specific side effects for ZB131 are not listed as it's first-in-human use, common side effects from similar cancer therapies may include fatigue, nausea, infusion reactions like fever or chills, blood count changes increasing infection risk; liver or kidney function alterations; allergic reactions; and potentially others based on individual patient response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum plasma concentration (Cmax)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active Treatment: ZB131Experimental Treatment1 Intervention
During the Dose Escalation Stage, patients will be treated with ZB131 at increasing dose levels, beginning with a starting dose level (DL0) of 3 mg/kg once weekly, up to a maximum dose level (DL3) of 15 mg/kg once weekly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZB131
2022
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

ZielBio, Inc.Lead Sponsor
Ramesh Ramanathan, MDStudy DirectorZielBio, Inc.
2 Previous Clinical Trials
81 Total Patients Enrolled
Brian Schwartz, MDStudy DirectorZielBio, Inc.
1 Previous Clinical Trials

Media Library

ZB131 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05074472 — Phase 1 & 2
Pancreatic Cancer Research Study Groups: Active Treatment: ZB131
Pancreatic Cancer Clinical Trial 2023: ZB131 Highlights & Side Effects. Trial Name: NCT05074472 — Phase 1 & 2
ZB131 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074472 — Phase 1 & 2
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT05074472 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently enrolling participants?

"Affirmative. Per clinicaltrials.gov, this medical trial is recruiting participants as of now; it was initially posted on January 14th 2022 and was most recently modified on August 31st 2022. 37 volunteers must be sought from 9 distinct study sites."

Answered by AI

How many medical institutions are active participants in this research?

"Presently, the trial is recruiting at nine sites across America. Some of these include Mayo Clinic - Phoenix in Arizona, Mayo Clinic - Rochester in Minnesota and MD Anderson Cancer Centre located in Houston Texas."

Answered by AI

What is the scope of enrolment for this research experiment?

"Affirmative. According to clinicaltrials.gov, recruitment for this study is currently underway - it was initially posted on 14th January 2022 and last modified on 31st August 2022. A total of 37 participants from 9 distinct medical sites are being sought after."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
NEXT Oncology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have been asked / told me that I am responsible for researching Clinical trials. I am very motivated to live given the type of cancer I have.
PatientReceived 1 prior treatment
~11 spots leftby Apr 2025