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Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

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

NCT04180371•BicycleTx Limited

View on ClinicalTrials.gov

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.

Detailed 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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•General Inclusion:
•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.
+6 more criteria

Exclusion Criteria

•Chemotherapy treatments within 14 days prior to first dose of study treatment, other anticancer treatments, treatment within 28 days or 5 half-lives, whichever is the shorter
•Experimental treatments within 4 weeks of first dose of BT5528
•Prior toxicities must have resolved to Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 (except alopecia which can be Grade 2), or well-controlled Grade 2 hypothyroidism or Grade 2 adrenal insufficiency on appropriate therapy
•Current treatment with strong inhibitors or inducers of CYP3A4 or strong inhibitors of P-gp
•Known sensitivity to any of the ingredients of the investigational product or monomethyl auristatin E (MMAE)
•Any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or is not in the best interest of the patient to participate in the opinion of the investigator including but not limited to specific cardiovascular criteria
•Major surgery (excluding placement of vascular access) within 4 weeks of first dose of BT5528 study treatment and must have recovered adequately prior to starting study therapy
•Receipt of live vaccine within 30 days of study treatment
•Untreated CNS metastases or leptomeningeal disease
•Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg that is not responsive to intervention) at screening or prior to initiation of study drug.
+22 more criteria

Locations (28)

California Cancer Associates for Research and Excellence, Inc.

Encinitas, California, United States

University of California - Irvine Medical Center

Orange, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Stephenson Cancer Center (Oklahoma University)

Oklahoma City, Oklahoma, United States

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

November 7, 2019

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2027

Last Updated

November 17, 2025

Enrollment

288

ESTIMATED participants

Conditions

Advanced Solid Tumor Historically Known for High EphA2 ExpressionUrothelial CancerOvarian CancerNon-small Cell Lung CancerHead and Neck CancerTriple Negative Breast CancerGastric/Upper Gastrointestinal Cancer

Interventions

BT5528

DRUG

Nivolumab

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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