drugset / Trial / NCT07016997
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
Timeline
- Start
- 2022-06-27
- Primary completion
- 2025-12-31
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CBA-1535 | Protein / enzyme biologic | 0.1 ug | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |