RecruitingSoft-tissue SarcomaTriple Negative Breast CancerNon-small Cell Lung Cancer
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of California, Irvine
You may qualify if…
- ✓ 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 therapies.
- ✓ Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.
- ✓ Disease that is considered measurable by RECIST v1.1.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- ✓ Life expectancy of at least 12 weeks.
- ✓ Human Immunodeficiency Virus (HIV)-positive trial participants should be on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- ✓ Left ventricular ejection fraction \> 50%.
You may not qualify if…
- ✕ Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.
- ✕ Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- ✕ Untreated metastases to the Central Nervous System (CNS).
- ✕ Have received any prior doxorubicin or anthracycline equivalent.
- ✕ Previous radiation to the mediastinal or pericardial area.
- ✕ A known allergy to albumin.
- ✕ HIV infection with CD4+ count \< 350 cells/µL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in previous 12 months.
- ✕ Pregnant (positive serum or urine pregnancy test) or lactating.
Where it's recruiting
California
Orange
Source: ClinicalTrials.gov · NCT07064018 · last updated 2026-07-17