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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07064018
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spedox-6 — DRUG
    Given Intravenously (IV)
  • Pegfilgrastim — DRUG
    Given Subcutaneous Injection or IV
  • Filgrastim — DRUG
    Given Subcutaneous Injection or IV

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
67 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Overall Response Rate (ORR) by RECIST v1.1 [ Time Frame: 2 Years ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical Center

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center University of California, IrvineOrangeCalifornia92868
Warren Chow, MD
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center University of California, Irvine· Orange, CA

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