NCT05074472

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: ZielBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

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

Timeline

• Start date: 2022-01-14
• Primary completion: 2023-08-30
• Completion: 2023-09-30
• First posted: 2021-10-12
• Last updated: 2024-01-29

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study