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

Description

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.

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor Historically Known for High EphA2 Expression
Intervention / Treatment

-

Contacts and Locations

Encinitas

California Cancer Associates for Research and Excellence, Inc., Encinitas, California, United States, 92024

La Jolla

University of California, San Diego (UCSD) - Medical Center, La Jolla, California, United States, 92037

Orange

University of California - Irvine Medical Center, Orange, California, United States, 92868

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Las Vegas

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States, 89169

New York

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

Oklahoma City

Stephenson Cancer Center (Oklahoma University), Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    BicycleTx Limited,

    Meredith McKean, MD, MPH, STUDY_CHAIR, Sarah Cannon and HCA Research Institute

    Study Record Dates

    2025-10-01