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

NCT07064018 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 6228UCI 24-08
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate (ORR) by RECIST v1.1

  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

  2 Years

• Disease Control Rate (DCR) by RECIST v1.1

  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).

  2 Years

• Complete Response Rate by RECIST v1.1

  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.

  2 years

• Partial Response Rate by RECIST v1.1

  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

  2 years

Secondary Outcomes (9)

• Stable Disease Rate by RECIST v1.1

  2 years

• Percentage of Responders by RECIST v1.1

  2 years

• Overall Survival

  2 years

• Progression Free Survival

  2 years

• Number of Patients with Grade 3 non-hematological toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  2 years

Other Outcomes (2)

• Correlation between Tumor FcRn Expression (IHC Score) and Objective Response (per RECIST v1.1)

  2 years

• Correlation between Tumor FcRn Expression (IHC Score) and Disease Control (CR + PR + SD per RECIST v1.1)

  2 years

Study Arms (8)

Phase 1b Dose Level 1 - Spedox-6

EXPERIMENTAL

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

Drug: Spedox-6

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

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

EXPERIMENTAL

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.

Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim

Interventions

Spedox-6 DRUG

Given Intravenously (IV)

Phase 1b Dose Level 1 - Spedox-6; Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim

Pegfilgrastim DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim

Filgrastim DRUG

Given Subcutaneous Injection or IV

Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim; Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Irvine: lead
• Sunstate Biosciences LLC: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Uterine Cervical Neoplasms; Ovarian Neoplasms

Interventions

pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Warren Chow, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical Center

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Division of Hematology-Oncology, Department of Medicine, UCI School of Medicine

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 14, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)