NCT04180371

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

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: BicycleTx Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BT5528 consists of a bicyclic peptide (Bicycle®) which binds to EphA2, and is covalently attached to a spacer and a protease cleavable peptide linker attached to MMAE. The Phase I/II multi-center, open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab. The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine recommended Phase II dose(s) (RP2D). Following selection of a recommended Phase II dose(s) (RP2D), a dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528.

Conditions

• Advanced Solid Tumor Historically Known for High EphA2 Expression
• Urothelial Cancer
• Ovarian Cancer
• Non-small Cell Lung Cancer
• Head and Neck Cancer
• Triple Negative Breast Cancer
• Gastric/Upper Gastrointestinal Cancer

Interventions

Type	Name	Description
DRUG	BT5528	Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose.
DRUG	Nivolumab	Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks.

Timeline

• Start date: 2019-11-07
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2019-11-27
• Last updated: 2025-11-17

Locations

28 sites across 5 countries: United States, Belgium, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study