Actively Recruiting
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Led by University of California, Irvine · Updated on 2025-07-14
67
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
S
Sunstate Biosciences LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at first screening
- Advanced solid tumors confirmed by histology or cytology, including STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma
- Tumors measurable by RECIST v1.1
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- HIV-positive participants must be on antiretroviral therapy for at least 4 weeks with viral load less than 400 copies/mL
- Left ventricular ejection fraction greater than 50%
- Adequate organ function including hemoglobin ≥10 g/dL, ANC ≥1,000/µL, platelets ≥100,000/µL, serum bilirubin ≤4.5x ULN unless Gilbert's disease, AST and ALT ≤3x ULN, and creatinine clearance >50 mL/min
- For patients with Gilbert's disease, serum unconjugated bilirubin less than 4 mg/dL
- At least 3 weeks since last chemotherapy, 4 weeks since last radiotherapy, immunotherapy, targeted therapy, or surgery
- Recovery from prior therapy toxicities to grade 1 or baseline except alopecia
- Negative pregnancy test within 7 days prior to treatment for females of reproductive potential
- Use of effective contraception for females of reproductive potential during and 6 months after study
- Use of effective contraception or vasectomy for males of reproductive potential during and 6 months after study
You will not qualify if you...
- Patients with cancers having known driver mutations with effective targeted therapies who have not received those therapies
- Unstable angina, angioplasty, cardiac stenting, or myocardial infarction within 6 months prior to study
- Untreated metastases to the central nervous system
- Prior treatment with doxorubicin or anthracycline equivalent
- Previous radiation to the mediastinal or pericardial area
- Known allergy to albumin
- HIV infection with CD4+ count less than 350 cells/µL or AIDS-defining opportunistic infection in past 12 months
- Pregnant or lactating women
- Treatment with investigational agents or non-approved drug/device use within 4 weeks prior to study
- Uncontrolled diabetes mellitus
- Need for strong inhibitors or inducers of CYP3A4, CYP2D6, or P-glycoprotein during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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