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SPEDOX-6 for Advanced Cancers

This study is testing a new drug called SPEDOX-6 for people with advanced cancers that haven't responded to at least two previous treatments. These cancers include soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical cancer, and ovarian cancer. The study is also looking at people with KRAS mutated tumors. Researchers want to find the best dose of SPEDOX-6 and see how well it shrinks tumors or stops them from growing. Success will be measured by how many people experience tumor shrinkage (Overall Response Rate) or stable disease (Disease Control Rate) over two years. You would receive SPEDOX-6 intravenously (through a vein).

Study design
This is a Phase 1b/IIa dose escalation study, meaning researchers are looking for the best dose of SPEDOX-6. It plans to enroll 67 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years to see how well the treatment works.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07064018

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~67 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Spedox-6PegfilgrastimFilgrastim

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR) by RECIST v1.1
Measured over 2 Years
+3 more outcomes measured

Conditions

Soft-tissue Sarcoma
Triple Negative Breast Cancer
Non-small Cell Lung Cancer
Cervical Cancer
Ovarian Cancer
KRAS Mutation-Related Tumors

Explore related trials

Cervical CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic Ductal AdenocarcinomaSoft Tissue SarcomaSolid NeoplasmTriple-negative breast cancerGTPase KRas

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Warren Chow, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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).

What this trial measures

  • Overall Response Rate (ORR) by RECIST v1.12 Years

    Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR

  • Disease Control Rate (DCR) by RECIST v1.12 Years

    Disease Control Rate (DCR) defined as Sum of Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).

  • Complete Response Rate by RECIST v1.12 years

    Complete Response Rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is defined as the disappearance of all target lesions.

  • Partial Response Rate by RECIST v1.12 years

    Partial Response rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions