NCT07064018 Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
| NCT ID | NCT07064018 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Soft-tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 67 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 67 participants in total. It began in 2025-04-30 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-8839
Warren Chow, MD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07064018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft-tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07064018 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07064018 currently recruiting?
Yes, NCT07064018 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT07064018 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT07064018 clinical trial?
NCT07064018 is sponsored by University of California, Irvine. The principal investigator is Warren Chow, MD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 67 participants.