Actively Recruiting
Phase Ib/IIa 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
104 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
Researchers are evaluating SPEDOX-6, a single protein encapsulated doxorubicin, in a Phase 1b/IIa clinical trial for adults with advanced, therapy-resistant cancers including soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical cancer, ovarian cancer, and KRAS mutant pancreatic ductal adenocarcinoma. The trial focuses on patients who have not previously received anthracycline treatments and aims to find the recommended dose for further studies. Participants receive SPEDOX-6 intravenously on day 1 of each 21-day cycle, with dose levels ranging from 20 mg/m2 to 310 mg/m2 across different groups. Treatment lasts for up to 6 cycles. Some groups also receive injections of filgrastim or pegfilgrastim to support blood cell counts, given according to standard protocols either subcutaneously or intravenously. Throughout the study, researchers monitor tumor response using RECIST v1.1 criteria over 2 years, looking at rates of overall response, disease control, complete and partial responses. Safety is assessed by tracking side effects and toxicities. Participants undergo regular evaluations including physical exams, lab tests, and imaging to measure treatment effects and manage any adverse events. The trial is designed to last up to 2 years with ongoing follow-up to assess survival and disease progression.
CONDITIONS
Brief 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 visit
- Advanced solid tumors confirmed by biopsy, including soft-tissue sarcoma, triple-negative breast cancer, cervical cancer, non-small cell lung cancer, ovarian cancer, and KRAS mutant pancreatic ductal adenocarcinoma
- Tumors measurable by RECIST v1.1 criteria
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- HIV-positive participants on stable antiretroviral therapy with viral load below 400 copies/mL
- Left ventricular ejection fraction greater than 50%
- Adequate organ function including hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function
- Recovery from prior cancer therapies and appropriate washout periods before study entry
- Negative pregnancy test for females of reproductive potential and agreement to use effective contraception
- Males of reproductive potential must agree to use effective contraception during and 6 months after treatment
You will not qualify if you...
- Cancers with known driver mutations having effective targeted therapies not yet received but available
- Unstable angina, recent angioplasty, stenting, or heart attack within 6 months
- Untreated brain metastases
- Prior treatment with doxorubicin or anthracycline
- Previous radiation to mediastinal or pericardial area
- Known allergy to albumin
- HIV infection with low CD4 count or recent AIDS-defining infections
- Pregnant or breastfeeding women
- Recent treatment with investigational agents or unapproved drugs within 4 weeks
- Uncontrolled diabetes mellitus
- Need for strong inhibitors or inducers of certain liver enzymes or drug transporters during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive Spedox-6 chemotherapy intravenously on Day 1 of each 21-day cycle, for a total of 6 cycles. Depending on the dose level, participants may also receive Filgrastim or Pegfilgrastim by injection according to institutional standards.
6 visits (in-person) for chemotherapy administration; additional visits as needed for Filgrastim or Pegfilgrastim injections
Duration - Up to 2 years
Participants are monitored for response to treatment and side effects for up to 2 years after treatment completion.
Regular follow-up visits as scheduled by the study team
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
U
University of California Irvine Medical Center
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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