A Study of BND-35 in Participants With Advanced Solid Tumors
Summary
This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab.
Timeline
- Start
- 2024-06-02
- Primary completion
- 2026-04-29
- Completion
- 2026-04-29
Outcome
Outcome not reported
Stopped (Business): “Study terminated due to strategic considerations”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BND-35 | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | BND-35 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | BND-35 | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |