What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy regimens such as gemcitabine plus nab-paclitaxel and FOLFIRINOX. Known side effects of these treatments include neutropenia, fatigue, neuropathy, nausea, diarrhea, and thrombocytopenia. In the context of treatments targeting CSP in solid tumors, such as the ZB131 trial, side effects may also include general chemotherapy-related toxicities like neutropenia and fatigue, as well as specific toxicities related to the novel agent being studied. Patients should discuss potential side effects with their healthcare provider to understand the risks and benefits of their treatment options.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer have primarily focused on chemotherapy regimens. Notable approvals include FOLFIRINOX (a combination of leucovorin, fluorouracil, irinotecan, and oxaliplatin) and gemcitabine-based therapies, such as gemcitabine plus nab-paclitaxel. These treatments aim to improve survival and manage symptoms in advanced stages. While there is no specific mention of CSP-targeting drugs like ZB131 in the context provided, ongoing research and trials continue to explore novel targets and mechanisms to enhance treatment efficacy for pancreatic cancer.

What other types of research exist?

Promising novel alternatives to ZB131 for pancreatic cancer patients include the dendritic cell vaccine loaded with WT1 peptides (TLP0-001) in combination with S-1, targeting mTOR, and immune checkpoint inhibitors such as pembrolizumab and dostarlimab for patients with specific genetic profiles (dMMR or high TMB).

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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

No Placebo-Only Group

Summary

This trial is testing a new drug called ZB131, given regularly, in individuals with certain types of growths. These individuals are chosen because their growths have high levels of a specific substance. The drug aims to slow or stop the growth by targeting this substance.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum plasma concentration (Cmax)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

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.