BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumors Malignancies
1-800-641-2422
Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
- Sex at Birth: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I
- Conditions Being Studied: Cancer - Solid Tumor
Study Purpose
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).
Locations
UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: STUDY20210967
- StudyID: BTX1Y21
- ClinicalTrials.gov: NCT04561362
1-800-641-2422
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