Who is eligible for clinical trial NCT05163041?

Participants must meet the protocol's inclusion criteria for Advanced Solid Tumor. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05163041 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-01-14

Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression (NCT05163041)

Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: BicycleTx Limited

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (9 items).

Location: State University of Iowa — Iowa City, Iowa

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (9 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Solid Tumor

Phase 1/2 Study of TU2218 Alone and in Combination With Checkpoint Inhibitors in Patients With Advanced Solid Tumors — San Antonio, Texas
Study in Advanced Solid Tumor Patients — Boston, Massachusetts
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors — La Jolla, California
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors — Encinitas, California
A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors — Los Angeles, California

Explore by condition: All Advanced Solid Tumor clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗