Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around
Principal Investigator
by Misako Nagasaka, MD (uci)

Description

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.

Official Title

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

Details

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.

Keywords

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, EphA2, bladder cancer, NSCLC, TNBC, gastric cancer, GEJ cancer, HNSCC, Ovarian Neoplasms, Triple Negative Breast Neoplasms, Gastrointestinal Neoplasms, Nivolumab

Eligibility

Locations

  • University of California, San Diego (UCSD) - Medical Center withdrawn
    La Jolla California 92037 United States
  • University of California - Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • California Cancer Associates for Research and Excellence, Inc. accepting new patients
    Encinitas California 92024 United States

Lead Scientist at University of California Health

  • Misako Nagasaka, MD (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 174 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BicycleTx Limited
ID
NCT04180371
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 288 study participants
Last Updated