Single Protein Encapsulated Doxorubicin for the Treatment of Advanced, Refractory or Relapsed Solid Tumor Malignancies

Inclusion Criteria

• Subjects ≥ 18 years at the first screening examination/visit
• Subjects with advanced histologically or cytologically confirmed solid tumors refractory to or relapse from at least two previous therapies
• Tumor types expected to express lower levels of FcRn relative to normal tissue including: soft tissue sarcoma (STS), triple negative breast cancer (TNBC), cervical cancer, non-small cell lung cancer (NSCLC), ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level
• Disease that is considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy of at least 12 weeks
• 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%
• Hemoglobin (Hb) ≥ 10 g/dL
• Absolute neutrophil count (ANC) ≥ 1,000/µL3
• Platelets ≥ 100,000/µL3
• Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN) (unless known Gilbert’s disease)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
• 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 Common Terminology Criteria for Adverse Events (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 (C1D1) 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
• 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

Exclusion Criteria

• 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 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 within 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)