ACTIVE_NOT_RECRUITING

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

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Conditions

Urinary Bladder NeoplasmTriple Negative Breast NeoplasmsHormone Receptor Positive, HER2-negative NeoplasmsHormone Receptor Positive, HER2-low NeoplasmsBreast NeoplasmsNon-Small-Cell Lung NeoplasmsOvarian NeoplasmAdvanced Solid TumorNectin-4Solid tumorTransitional urothelial carcinomaRenal insufficiency

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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 study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).

Official Title

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

Quick Facts

Study Start:2020-07-17
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04561362

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Meredith McKean, MD, MPH
STUDY_CHAIR
Tennessee Oncology

Study Locations (Sites)

Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Advent Health
Orlando, Florida, 34747
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: BicycleTx Limited

  • Meredith McKean, MD, MPH, STUDY_CHAIR, Tennessee Oncology

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 Date2020-07-17
Study Completion Date2026-12

Study Record Updates

Study Start Date2020-07-17
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Nectin-4
  • Solid tumor
  • Transitional urothelial carcinoma
  • Renal insufficiency

Additional Relevant MeSH Terms

  • Urinary Bladder Neoplasm
  • Triple Negative Breast Neoplasms
  • Hormone Receptor Positive, HER2-negative Neoplasms
  • Hormone Receptor Positive, HER2-low Neoplasms
  • Breast Neoplasms
  • Non-Small-Cell Lung Neoplasms
  • Ovarian Neoplasm
  • Advanced Solid Tumor