drugset / Trial / NCT05220748
RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A phase 1a/1b, open-label, RM-1995 drug-dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of RM-1995 photoimmunotherapy treatment as monotherapy (phase 1a) or combined with pembrolizumab (phase 1b) in patients with cutaneous squamous cell carcinoma (cuSCC) or head and neck squamous cell carcinoma (HNSCC) that has progressed despite all available standard therapies.
Timeline
- Start
- 2022-03-24
- Primary completion
- 2023-01-30
- Completion
- 2023-01-30
Outcome
Outcome not reported
Stopped (Enrollment): “Decision was made due to a strategic re-evaluation of pipelines; no patients were enrolled.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | RM-1995 | Unknown | 0.25 mg/kg | Intravenous |
| Subject | RM-1995 | Unknown | 2 mg/kg | Intravenous |