Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumors Malignancies
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- STATUS
- Recruiting
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- End date
- Jun 9, 2023
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- participants needed
- 172
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- sponsor
- BicycleTx Limited
Summary
This clinical trial is evaluating a drug called BT8009 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.
The main goals of this study are to:
- Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with nivolumab
- Learn more about the side effects and effectiveness of BT8009 alone and in combination with nivolumab
- Learn more about BT8009 alone and in combination with nivolumab
- Learn more about BT8009 alone in patients with kidney disease
Description
BT8009 consists of a Bicycle peptide (Bicycle®) which binds selectively to Nectin-4, and is covalently attached to a spacer and a cleavable linker attached to a cytotoxin (MMAE).
This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent given once weekly and in combination with nivolumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with nivolumab and to determine a recommended Phase II dose (RP2D). Following a selection of a recommended Phase II dose (RP2D), part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with nivolumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of chosen RP2D of BT8009 in patients with renal insufficiency.
Details
| Condition | Advanced Solid Tumor, Urinary Bladder Neoplasm, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasm, Esophageal Neoplasms, Ovarian Neoplasm |
|---|---|
| Treatment | Nivolumab, BT8009 |
| Clinical Study Identifier | NCT04561362 |
| Sponsor | BicycleTx Limited |
| Last Modified on | 9 August 2022 |
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