MedTrace Logo

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

NCT04180371 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BT5528

Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose.

DRUG

Nivolumab

Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks.

Sponsors & Collaborators

  • BicycleTx Limited

    lead INDUSTRY

Principal Investigators

  • Meredith McKean, MD, MPH · Sarah Cannon and HCA Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04180371 on ClinicalTrials.gov