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

NCT05074472 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-01-29

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumor, Adult
  • Pancreatic Ductal; Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Biliary Cancer Metastatic
  • Ovarian Serous Cystadenocarcinoma

Interventions

DRUG

ZB131

ZB131 will be administered once weekly by intravenous infusion with the weight at baseline used for mg/kg dose calculations.

Sponsors & Collaborators

  • ZielBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Ramesh Ramanathan, MD · ZielBio, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2023-08-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074472 on ClinicalTrials.gov