NCT06413615

A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors

Name: Clinical Trial NCT06413615
Creator: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Keywords: Advanced Solid Tumor, FDA022-BB05, Phase 2, drug, clinical trial, China

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients With Advanced/Metastatic Solid Tumors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.·Phase 2·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Advanced Solid Tumor
Drug/Device/Intervention: FDA022-BB05
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Location: Shanghai, China

Timeline & enrollment

Phase: Phase 2
Start date: May 13, 2024
End date: Jun 30, 2026
Enrollment: 150 participants

Primary outcome

Objective Response Rate (ORR),Occurrence of adverse events (AEs) and serious adverse events (SAEs)

Summary

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.

ICD-10 classifications

Carcinoma in situ, unspecifiedMalignant neoplasm: PrepuceMalignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissue

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06413615
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06413615 through Pure Global AI's free database. This Phase 2 trial is sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Advanced Solid Tumor. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.