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

Solid Tumor, Adult Clinical Trial

Official title: A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. Once the RP2D has been established, the Dose Expansion stage will begin to enroll subjects by cohort. For each expansion cohort, subjects will be enrolled in two stages. The first stage includes an evaluation of 12 patients. If 1 or more of 12 patients have a CR or PR, then accrual will continue until a total of 37 patients with measurable disease have been enrolled. Additional patients may be added to ensure 37 subjects with measurable disease are available for evaluation ;

Related Conditions & MeSH terms

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

• NCT number: NCT05074472
• Study type: Interventional
• Source: ZielBio, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 14, 2022
• Completion date: September 30, 2023