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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine and S-1, which work by interfering with DNA replication in cancer cells, leading to cell death. Targeted therapies, like PARP inhibitors, exploit specific genetic vulnerabilities in cancer cells, such as BRCA mutations, to prevent DNA repair and induce cell death.
Immunotherapies, including immune checkpoint inhibitors, enhance the body's immune response against cancer cells. These treatments are crucial for pancreatic cancer patients as they offer different mechanisms to attack the cancer, potentially improving outcomes.
The trial ZB131, which targets CSP in solid tumors, represents a novel approach by focusing on specific proteins expressed in cancer cells, aiming to improve the precision and effectiveness of treatment.
Current and future strategies for combined-modality therapy in pancreatic cancer.
Current and future strategies for combined-modality therapy in pancreatic cancer.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of cancer that starts in the brain.You have received a live vaccine in the last 6 weeks before starting the study drug.The study is looking for participants who have advanced or metastatic pancreatic, ovarian, or biliary cancer and have not responded to or are not eligible for standard treatment.You have advanced cancer that has not responded to standard treatment, and there are no other available treatments that can cure your cancer.You have severe digestive problems, such as a blocked intestine, within 4 weeks before the study.You need medication that reduces your immune system's activity.You cannot have received a COVID-19 vaccine within a week before the start of the study, and you cannot receive a vaccine or booster less than 3 weeks before a tumor assessment during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment: ZB131
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pancreatic Cancer Patient Testimony for trial: Trial Name: NCT05074472 — Phase 1 & 2
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