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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling or analyses

• At least 18 years-of-age at the time of signature of the informed consent form

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

• Acceptable renal, hepatic, hematologic and coagulation functions

• Negative pregnancy test for women of childbearing potential

• Male participants with female partners of childbearing potential and female participants of childbearing potential are required to follow highly effective contraception

• All patients must have tumor tissue (fresh or archived) available for analysis of EphA2 tumor expression and other biomarkers. In the absence of available tumor tissue, patients must be willing to undergo a biopsy to provide fresh tumor samples

• Life expectancy ≥12 weeks after the start of BT5528 treatment according to the Investigator's judgment.

• Must be willing and able to comply with the protocol and study procedures.

⁃ Additional inclusion criteria for Phase I (dose escalation phase, with BT5528 alone or in combination with nivolumab):

• Metastatic recurrent histologically confirmed malignant solid tumors historically known for high EphA2 tumor expression. Confirmation of EphA2 expression prior to enrollment is not required for participants with ovarian cancer and specific other individual tumor types.

• Exhausted all appropriate treatment options per local guidelines

• Participants with urothelial cancer who have at least 1 (but no more than 3) prior lines of systemic therapy.

⁃ Additional inclusion criteria for Phase II (dose expansion phase, with BT5528 alone):

• Participants with metastatic recurrent disease histologically confirmed to be non-small cell lung cancer, ovarian cancer, triple-negative breast cancer (TNBC), gastric/upper gastrointestinal (GI) cancer, head and neck (H\&N) cancer, urothelial cancer are eligible and must have failed or are ineligible for all appropriate treatment options per local guidelines and must have evidence of radiographic progression on the most recent line of therapy

• Patients with urothelial cancer who have previously received treatment with enfortumab vedotin (EV) are eligible to the study. Patients who received EV and showed disease progression within 6 months of treatment start are planned for less than 50% of total patients enrolled in the cohort

Locations
United States
California
California Cancer Associates for Research and Excellence, Inc.
RECRUITING
Encinitas
University of California, San Diego (UCSD) - Medical Center
WITHDRAWN
La Jolla
University of California - Irvine Medical Center
RECRUITING
Orange
Colorado
Sarah Cannon Research Institute at HealthONE
RECRUITING
Denver
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Massachusetts
Dana Farber Cancer Institute
WITHDRAWN
Boston
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Nevada
Comprehensive Cancer Centers of Nevada
COMPLETED
Las Vegas
New York
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Oklahoma
Stephenson Cancer Center (Oklahoma University)
RECRUITING
Oklahoma City
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Rhode Island
Women and Infants Hospital
WITHDRAWN
Providence
Tennessee
Sarah Cannon and HCA Research Institute
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
WITHDRAWN
Milwaukee
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Institut Jules Bordet
RECRUITING
Brussels
Antwerp University Hospital (UZA)
RECRUITING
Edegem
Universitair Ziekenhuis Gent (UZ)
RECRUITING
Ghent
Republic of Korea
Gachon University Gil Medical Center
COMPLETED
Incheon
Severance Hospital, Yonsei University Health System
COMPLETED
Seoul
Spain
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Institut Catala d'Oncologia - L'Hospitalet
RECRUITING
Barcelona
Centro Integral Oncologico Clara Campal
RECRUITING
Madrid
Hospital Fundación Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
The Leeds Teaching Hospitals NHS Trust Of Trust Headquarters, St James's University Hospital
RECRUITING
Leeds
Sarah Cannon Research Institute UK
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Sir Bobby Robson Cancer Trials Research Centre, The Northern Center for Cancer Care, Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
BicycleTx Limited
clinicalstudies@bicycletx.com
617-945-8155
Time Frame
Start Date: 2019-11-07
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 288
Treatments
Experimental: Phase I - Dose escalation (BT5528)
Cohorts of participants will receive increasing doses of BT5528. It is expected that up to 72 participants will participate in this dose escalation arm.
Experimental: Phase I - Dose escalation combination (BT5528 & nivolumab)
Cohorts of participants will receive increasing doses of BT5528 and a standard dose of nivolumab. It is expected that up to 24 participants will participate in this dose-escalation combination arm.
Experimental: Phase II - Dose expansion 1 (BT5528)
A cohort of participants will receive the selected dose of BT5528 as a monotherapy. It is expected that up to 164 patients have solid tumors (Cohort 1: urothelial cancers, Cohort 2: ovarian cancer, Cohort 3: non-small cell lung cancer, Cohort 4: head and neck cancer, Cohort 5: triple-negative breast cancer, and Cohort 6: gastric/upper gastrointestinal cancer) historically known for high expression of EphA2 will participate in this dose-expansion arm, Cohort 7: urothelial MMAE exposed, Cohort 8: head and neck squamous cell carcinoma
Sponsors
Leads: BicycleTx Limited

This content was sourced from clinicaltrials.gov

Similar Clinical Trials