CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
AB-16B5 +1 moredrug
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/NCT04364620
NCT04364620Phase 2Completed

A Phase II Study of AB-16B5 Combined With Docetaxel in Previously Treated Subjects With Metastatic Non-Small Cell Lung Cancer (EGIA-002)

Alethia Biotherapeutics·interventional·Posted Apr 28, 2020·Updated Apr 6, 2025

In Brief

A Phase 2 clinical trial evaluating AB-16B5 and Docetaxel for NSCLC Stage IV. Completed, enrolled 35 participants across 5 sites in 2 countries.

Detailed Summary

This Phase II study will recruit 40 metastatic non-small cell lung cancer patients who failed treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody, administered simultaneously or sequentially. All recruited patients will receive AB-16B5 at a dose of 12 mg/kg once weekly combined with docetaxel at a dose of 75 mg/m2 once every 3 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC Stage IV
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartFeb 23, 2021
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.2 years ago

Interventions

AB-16B5drug

AB-16B5 is an inhibitor of the epithelial to mesenchymal transition. It is a fully humanized monoclonal antibody of IgG2 isotype against tumor-associated secreted clusterin (TA-sCLU).

Docetaxeldrug

Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer