Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
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.
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
Quick Facts
Study Start:2019-11-07
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING
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.
| Inclusion Criteria | Exclusion Criteria |
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Contacts and Locations
Study Locations (Sites)
California Cancer Associates for Research and Excellence, Inc.
Encinitas, California, 92024
United States
University of California - Irvine Medical Center
Orange, California, 92868
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Stephenson Cancer Center (Oklahoma University)
Oklahoma City, Oklahoma, 73104
United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37221
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Collaborators and Investigators
Sponsor: BicycleTx Limited
- Meredith McKean, MD, MPH, STUDY_CHAIR, Sarah Cannon and HCA Research Institute
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2019-11-07
Study Completion Date2027-07-31
Study Record Updates
Study Start Date2019-11-07
Study Completion Date2027-07-31
Terms related to this study
Keywords Provided by Researchers
- EphA2
- ovarian cancer
- urothelial cancer
- bladder cancer
- NSCLC
- TNBC
- gastric cancer
- GEJ cancer
- HNSCC
Additional Relevant MeSH Terms
- 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