Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
NCT #
NCT04561362
Condition(s)
Breast Cancer, Lung Cancer (NSCLC), Ovarian/ Peritoneal/ Fallopian Tube Cancer, Urothelial Cancer
Molecular Target(s)
Nectin-4
Drug Classification(s)
Antibody Drug Conjugate
Agents(s)
BT8009
Phase(s)
I/II
Mechanism of Action
BT8009 selectively binds to nectin-4. After internalization and proteolytic cleavage by peptidases that are upregulated in the tumor microenvironment (TME), MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells.
Purpose
- How much of the study drug alone and in combination with Pembrolizumab can be given with an acceptable level of side effects
- The effects of the study drug alone and in combination with Pembrolizumab (good and bad)
- How much of the study drug alone and in combination with Pembrolizumab is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from BT8009 alone and in combination with Pembrolizumab
- How the study drug alone and in combination with Pembrolizumab acts in the body
Location
MCD
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