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Clinical trialNCT05074472CompletedPhase 1/PHASE2Interventional

A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors

SponsorZielBio, Inc.Enrollment35Biliary Cancer MetastaticOvarian Serous AdenocarcinomaOvarian Serous CystadenocarcinomaPancreatic Ductal; AdenocarcinomaSolid Tumor, Adult
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where prevalence of CSP expression is high. Approximately 12 to 24 patients will be enrolled in the Dose Escalation Stage; the total number of patients will depend on the dose level at which the RP2D is defined. Patients who meet the eligibility criteria during Screening will enter the treatment period. ZB131 will be given via IV every week. Patients will be treated until disease progression or unacceptable toxicities occur.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mayo Clinic - Phoenix

    Phoenix, Arizona, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, United States

  • Next Oncology

    Austin, Texas, United States

  • Md Anderson Cancer Center

    Houston, Texas, United States

  • Next Oncology

    San Antonio, Texas, United States

  • University of Virginia

    Charlottesville, Virginia, United States

  • Next Onoology

    Fairfax, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ZB131
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Jan 2022
Primary completion
30 Aug 2023
Completion
30 Sept 2023
Last update posted
29 Jan 2024
Registered enrollment
35
Registry id
NCT05074472

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.