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A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors - Trial NCT06413615

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.

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NCT06413615
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06413615
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A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors
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

Study Focus

Advanced Solid Tumor

FDA022-BB05

Interventional

drug

Sponsor & Location

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

Shanghai, China

Timeline & Enrollment

Phase 2

May 13, 2024

Jun 30, 2026

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, unspecified
Malignant neoplasm: Prepuce
Malignant neoplasm: Connective and soft tissue, unspecified
Malignant neoplasm: Parametrium
Malignant neoplasm of other connective and soft tissue

Data Source

ClinicalTrials.gov

NCT06413615

Non-Device Trial