Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumors Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Carcinoma Non-small-cell Lung
- Esophageal Neoplasms
- Ovarian Neoplasm
- Pancreatic Neoplasms
- Stomach Neoplasm
- Triple Negative Breast Neoplasms
- Urinary Bladder Neoplasm
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 age...
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.
Tracking Information
- NCT #
- NCT04561362
- Collaborators
- Not Provided
- Investigators
- Study Chair: Meredith McKean, MD, MPH Tennessee Oncology, PLLC