Single-protein encapsulated doxorubicin (SPEDOX-6) for advanced solid tumors
Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
We will try SPEDOX-6, a protein-encapsulated form of doxorubicin, to find a safe dose and see if it helps adults with advanced, treatment-resistant solid tumors (including certain sarcomas, triple-negative breast cancer, non-small cell lung cancer, cervical, ovarian, and KRAS‑mutant pancreatic cancers) who have not received anthracyclines before.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, doxorubicin |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT07064018 on ClinicalTrials.gov |
What this trial studies
SPEDOX-6 is a formulation of doxorubicin encapsulated in a single protein intended to change drug distribution and potentially improve tumor delivery while lowering normal-tissue exposure. This Phase 1b/IIa dose-escalation trial enrolls adults with measurable, advanced solid tumors refractory to at least two prior therapies who are anthracycline‑naïve. Dose-escalation cohorts will identify a recommended Phase II dose based on safety, tolerability, and dose-limiting toxicities, while anti-tumor activity will be measured by RECIST v1.1. Protocol-allowed supportive care includes pegfilgrastim or filgrastim to manage neutropenia as needed.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with measurable, advanced solid tumors (STS, TNBC, NSCLC, cervical, ovarian, or KRAS‑mutant pancreatic cancer) refractory to at least two prior therapies, who are anthracycline‑naïve, have ECOG 0–2, and meet organ function and cardiac safety requirements.
Not a fit: Patients who have previously received anthracyclines, have inadequate organ function or poor performance status, uncontrolled comorbidities, or tumor types not specified in the protocol are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, SPEDOX-6 could offer an anthracycline option with improved tumor targeting and potentially fewer or different side effects for patients with anthracycline‑naïve, advanced solid tumors.
How similar studies have performed: Liposomal and other encapsulation strategies for doxorubicin have shown clinical benefit in some cancers, but single‑protein encapsulation like SPEDOX‑6 is a newer approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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%. * Adequate organ function: (Hb ≥10 g/dL, ANC ≥1,000/µL3, and platelets ≥100,000/µL3), serum bilirubin ≤.5x the institutional upper limit of normal (ULN) (unless known Gilbert's disease), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3x ULN, and creatinine clearance \>50 mL/min as assessed by Cockcroft-Gault equation. * For patients with known Gilbert's disease, serum unconjugated bilirubin must be \< 4 mg/dL. * Patient must have washed out of prior chemotherapy (at least 3 weeks from last end of therapy), radiotherapy (at least 4 weeks from last end of therapy), immunotherapy (at least 4 weeks from last end of therapy), other targeted therapies (at least 4 weeks from last end of therapy), or surgery (at least 4 weeks). * Recovery from toxicities of prior therapy. Toxicities should have recovered to CTCAE grade ≤ 1 or baseline with exception of alopecia. * Females of reproductive potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment. Additionally, female subjects of reproductive potential should agree to use effective acceptable forms of contraception: surgical sterilization (tubal ligation); total abstinence from sexual intercourse with the opposite sex; established hormonal birth control (e.g., oral, transdermal, injection, or implant) plus a barrier method or a double barrier method (intrauterine device, spermicide, or a diaphragm plus condom) for at least 1 month prior to Cycle 1 Day 1 and agreement to use such a method during study participation and for an additional 6 months after the last dose of SPEDOX-6. * For males of reproductive potential: vasectomy or highly effective contraception (e.g., condoms, abstinence) during the study and for an additional 6 months after the last dose of SPEDOX-6. Exclusion Criteria: * 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. * Previous treatment with an investigational agent or the non-approved use of a drug or device withing 4 weeks of study entry. * Uncontrolled diabetes mellitus. * Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P-glycoprotein (P-gp).
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Warren Chow, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.