drugset
drugset / Trial / NCT04180371

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

NCT04180371 ↗

Phase 1/2 Active not recruiting 288 enrolled BicycleTx Limited
Non-randomizedSequentialOpen-labelTreatment

Summary

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.

Timeline

Start
2019-11-07
Primary completion
2026-07-31
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BT5528 Other / unclassified — Intravenous
Background Nivolumab Monoclonal antibody 480 mg Intravenous

Indications

gastroesophageal cancer head and neck cancer non-small cell lung carcinoma ovarian cancer triple-negative breast carcinoma urothelial carcinoma