Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

This clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression. The main goals of the study are to: * Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab * Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab * Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body * Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney function

Key facts

Study ID

NCT05163041

Run by

BicycleTx Limited

People needed

200

Starts

2021-11-02

Expected to finish

2026-12-01

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator
• Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma
• Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function
• Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Life expectancy ≥12 weeks
• Must submit fresh or archival tumor tissue
• Must provide 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 analysis

You may not qualify if…

• Prior therapy with a cytotoxic, small molecule, or other systemic chemotherapy within 14 days of the first dose of study drug
• Prior immunotherapy, including monoclonal antibodies, within 28 days or 5 half-lives of the first dose of study drug, whichever is shorter
• Prior treatment with CD137 targeted therapy
• Mean resting QTc (eg, QTcF) greater than 470 msec on triplicate electrocardiograms (ECGs) obtained at screening
• Uncontrolled symptomatic brain metastases
• Uncontrolled diabetes with glycosylated hemoglobin greater than or equal to 8%
• Uncontrolled hypertension at screening or prior to initiation of study drug
• History of autoimmune disease except well-controlled diabetes mellitus, alopecia, well controlled thyroid disease or vitiligo

Where it is running

• State University of Iowa — Iowa City, Iowa, United States
• Columbia University Irving Medical Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• START Center for Cancer Care — San Antonio, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• The Royal Marsden NHS Foundation Trust — Sutton, Surrey, United Kingdom
• The Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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