drugset / Trial / NCT06249048
Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients with Advanced Solid Tumors as a Monotherapy or in Combination with Pembrolizumab. The study now includes a monotherapy cohort targeting visceral lesions and a separate Phase 2 monotherapy cohort for advanced melanoma.
Timeline
- Start
- 2024-05-03
- Primary completion
- 2027-05
- Completion
- 2028-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | STX-001 | Messenger RNA (mRNA) | 30 ug | Other |
| Subject | STX-001 | Messenger RNA (mRNA) | 100 ug | Other |
| Subject | STX-001 | Messenger RNA (mRNA) | 300 ug | Other |