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

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.

Trial Details

NCT ID
NCT07064018
Phase
PHASE1 / PHASE2
Sponsor
University of California, Irvine
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • Spedox-6
  • Pegfilgrastim
  • Filgrastim
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Subjects ≥ 18 years at the first screening examination/visit.
  • Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous thera…
  • Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KR…
  • Disease that is considered measurable by RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

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