drugset
drugset / Trial / NCT07064018

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

NCT07064018 ↗

Phase 1/2 Recruiting 67 enrolled University of California, Irvine Sunstate Biosciences LLC · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthracyclines.

Timeline

Start
2025-04-30
Primary completion
2029-12-31
Completion
2031-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Spedox-6 Unknown 20 mg/m2 Intravenous
Subject Spedox-6 Unknown 40 mg/m2 Intravenous
Subject Spedox-6 Unknown 80 mg/m2 Intravenous
Subject Spedox-6 Unknown 120 mg/m2 Intravenous
Subject Spedox-6 Unknown 160 mg/m2 Intravenous
Subject Spedox-6 Unknown 200 mg/m2 Intravenous
Subject Spedox-6 Unknown 250 mg/m2 Intravenous
Subject Spedox-6 Unknown 310 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic — Subcutaneous
Background filgrastim Protein / enzyme biologic — Subcutaneous

Indications

cervical cancer non-small cell lung carcinoma ovarian cancer soft tissue sarcoma triple-negative breast carcinoma