Clinical Trial

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

Recruiting Phase 1/2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-02.
Trial Details
NCT Number NCT07064018
Lead Sponsor University of California, Irvine
Collaborators: Sunstate Biosciences LLC
Conditions Soft-tissue Sarcoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, KRAS Mutation-Related Tumors
Enrollment 67 participants
Start Date 2025-04-30
Primary Completion 2029-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-17