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

NCT05163041 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-15

No results posted yet for this study

Summary

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

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

BT7480

Participants will receive a 60 minute IV infusion of BT7480 once weekly (i.e., on Days 1,8,15 and 22) during a 28-day cycle

DRUG

Nivolumab

Nivolumab will be given as a 240mg dose every 2 weeks administered as per local labelling as a 30 minute IV infusion

Sponsors & Collaborators

  • BicycleTx Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2026-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163041 on ClinicalTrials.gov