Phase 1/2Active, not recruiting
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
- Sponsor
- BicycleTx Limited (Industry)
- Enrollment
- 329 planned
- Conditions
- Urinary Bladder Neoplasm; Triple Negative Breast Neoplasms; Hormone Receptor Positive, HER2-negative Neoplasms; Hormone Receptor Positive, HER2-low Neoplasms; Breast Neoplasms; Non-Small-Cell Lung Neoplasms; Ovarian Neoplasm; Advanced Solid Tumor
- Interventions
- BT8009; Pembrolizumab
- Ages
- adults, older adults
- Registry
- NCT04561362
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Parts A-1, A-2 and C: Number of participants with treatment emergent adverse events, receiving BT8009 as a monotherapy or in combination with pembrolizumab to assess safety and tolerability.
- Parts A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 as a monotherapy or in combination with pembrolizumab
- Part B1-B7: Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab using RECIST 1.1.
- Part D: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
History
Primary completion expected
Last registry update
Registered
Started