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

NCT ID: NCT07064018

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2031-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b Dose Level 1 - Spedox-6

Spedox-6, 20 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 40 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 80 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 120 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 160 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 200 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 250 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim

Spedox-6, 310 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group Type: EXPERIMENTAL

Spedox-6

Intervention Type: DRUG

Given Intravenously (IV)

Pegfilgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Filgrastim

Intervention Type: DRUG

Given Subcutaneous Injection or IV

Interventions

Spedox-6

Given Intravenously (IV)

Intervention Type: DRUG

Pegfilgrastim

Given Subcutaneous Injection or IV

Intervention Type: DRUG

Filgrastim

Given Subcutaneous Injection or IV

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunstate Biosciences LLC

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Warren Chow

Professor - Division of Hematology-Oncology, Department of Medicine, UCI School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warren Chow, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical Center

Role: CONTACT

Facility Contacts

Warren Chow, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 24-08

Identifier Type: OTHER

Identifier Source: secondary_id

6228

Identifier Type: -

Identifier Source: org_study_id