CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 150 target
Drug / intervention
FDA022-BB05drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06413615
NCT06413615Phase 2RecruitingUpdate OverdueUpdated 21mo ago · Completion was 11mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

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.·interventional·Posted May 14, 2024·Updated Sep 26, 2024

In Brief

A Phase 2 clinical trial evaluating FDA022-BB05 for Advanced Solid Tumor. Currently recruiting, targeting 150 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20252026
First PostedMay 14, 2024
Enrollment StartMay 13, 2024
Primary CompletionJul 31, 2025
Study CompletionJun 30, 2026
TodayJul 1, 2026
Enrollment to primary: 1.2 yearsPosted 2.1 years ago

Interventions

FDA022-BB05drug

Monoclonal antibody-drug conjugate for injection