NCT05564858

A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.

Detailed description

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FDA022-BB05 in patients with advanced/metastatic solid tumors. FDA022-BB05 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify dose-limiting toxicities（DLT）and the maximum tolerated dose (MTD) through Day1 and Day 21 (cycle 1) with 1 dose. In addition, the recommended Phase II dose of FDA022-BB05 will be determined.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	FDA022 Monoclonal antibody-drug conjugate for injection Phase Ia	FDA022-BB05, intravenously infusion, q3w
DRUG	FDA022 Monoclonal antibody-drug conjugate for injection Phase Ib	FDA022-BB05, intravenously infusion, q3w

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-09-01
• Completion: 2025-11-01
• First posted: 2022-10-04
• Last updated: 2024-05-17

Locations

1 site across 1 country: China