drugset / Trial / NCT05116254
Sarcomas and DDR-Inhibition; a Combined Modality Study
Phase 1
Terminated
12 enrolled
The Netherlands Cancer Institute
Leiden University Medical Center · collabUniversity Medical Center Nijmegen · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
To assess the safety and tolerability profile, in the pre- and perioperative period (up to 30 days post-surgery), of combined modality treatment (CMT) by administering AZD1390 with or without durvalumab and RT concurrently treating newly diagnosed, non-metastatic soft tissue sarcoma patients with DDRi-based CMT, in the specific context of systemic toxicities, wound healing post-surgery and in defining the RP2D for the combinations to support further clinical evaluation.
Timeline
- Start
- 2022-07-18
- Primary completion
- 2025-12-09
- Completion
- 2025-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD1390 | Small molecule | 20 mg | Oral |
| Subject | AZD1390 | Small molecule | 100 mg | Oral |
| Subject | AZD1390 | Small molecule | 200 mg | Oral |
| Subject | AZD1390 | Small molecule | 400 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | — |