Last updated on June 2020

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

Brief description of study

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors that are believed to be associated with EphA2 expression. The main goals of this study are to:

  • Find the recommended dose of BT5528 that can be given safely to participants alone and in combination with nivolumab
  • Learn more about the side effects of BT5528
  • Learn more about BT5528 therapy alone and in combination with nivolumab.

Detailed Study 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 a recommended Phase II dose (RP2D). Following selection of a recommended Phase II dose (RP2D), a dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528.

Clinical Study Identifier: NCT04180371

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Florida Cancer Specialists

Sarasota, FL United States
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Recruitment Status: Open

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