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RECRUITING
NCT05564858
PHASE1

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

Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2023-01-16

Completion Date

2025-11

Last Updated

2024-05-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital

Beijing, Beijing Municipality, China