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

NCT07064018 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-07-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Spedox-6

Given Intravenously (IV)

DRUG

Pegfilgrastim

Given Subcutaneous Injection or IV

DRUG

Filgrastim

Given Subcutaneous Injection or IV

Sponsors & Collaborators

  • Sunstate Biosciences LLC

    collaborator INDUSTRY

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Warren Chow, MD · Chao Family Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2029-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064018 on ClinicalTrials.gov