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RECRUITING
NCT07064018
PHASE1/PHASE2

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Official title: Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2025-04-30

Completion Date

2031-12-31

Last Updated

2025-07-14

Healthy Volunteers

No

Interventions

DRUG

Spedox-6

Given Intravenously (IV)

DRUG

Pegfilgrastim

Given Subcutaneous Injection or IV

DRUG

Filgrastim

Given Subcutaneous Injection or IV

Locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States