- Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies — Active Not Recruiting • Phase I / Phase II • Oncology • NCT04561362.
- BT8009-100 Trial Summary.
- First-in-human trial testing BT8009 alone and with pembrolizumab in advanced cancers expressing Nectin-4 protein.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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). Conditions: Urinary Bladder Neoplasm, Triple Negative Breast Neoplasms, Hormone Receptor Positive, HER2-negative…