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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV
Experimental
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.
  • Drug: Spedox-6
    Given Intravenously (IV)
  • Drug: Pegfilgrastim
    Given Subcutaneous Injection or IV
  • Drug: Filgrastim
    Given Subcutaneous Injection or IV

Recruiting Locations

Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California 92868
Contact:
Warren Chow, MD
877-827-8839
ucstudy@uci.edu

More Details

Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
1-877-827-8839
ucstudy@uci.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.