drugset / Trial / NCT05813327
Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma
Phase 1
Active not recruiting
6 enrolled
Washington University School of Medicine
Polaris Group · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.
Timeline
- Start
- 2024-03-14
- Primary completion
- 2026-04-10
- Completion
- 2026-07-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ifosfamide | Small molecule | — | Intravenous |
| Subject | Pegargiminase | Protein / enzyme biologic | 36 mg/m2 | Intramuscular |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | Intravenous |