Protein-Wrapped chemo aims to hit tumors harder, spare healthy cells
NCT ID NCT07064018
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This trial tests SPEDOX-6, a version of the chemotherapy drug doxorubicin wrapped in a protein shell, in people with advanced solid tumors such as soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical cancer, ovarian cancer, and certain pancreatic cancers. The study aims to find the best dose and see whether the drug can shrink tumors or stop them from growing. Participants have already tried at least two other treatments without success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SPEDOX-6, a protein-encapsulated form of the chemotherapy drug doxorubicin, given intravenously
- What this could lead to
- If successful, SPEDOX-6 could offer a new treatment option for people with advanced cancers that have stopped responding to other therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or may cause significant side effects. Results may not apply to all cancer types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center University of California, Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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