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drugset / Trial / NCT05813327

Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma

NCT05813327 ↗

Phase 1 Terminated 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

Outcome

Outcome not reported

Stopped (Enrollment): “Polaris decided to close to accrual.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ifosfamide Small molecule — Intravenous
Subject Pegargiminase Protein / enzyme biologic 36 mg/m2 Intramuscular
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule — Intravenous

Indications

soft tissue sarcoma