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OncoMatch/Clinical Trials/NCT07064018

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

Is NCT07064018 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Spedox-6 and Pegfilgrastim for soft-tissue sarcoma.

Phase 1/2RecruitingUniversity of California, IrvineNCT07064018Data as of May 2026

Treatment: Spedox-6 · Pegfilgrastim · Filgrastim — 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Triple-Negative Breast Cancer

Breast Carcinoma

Non-Small Cell Lung Carcinoma

Cervical Cancer

Ovarian Cancer

Biomarker criteria

Required: KRAS mutation

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Cannot have received: doxorubicin or anthracycline equivalent

Have received any prior doxorubicin or anthracycline equivalent

Lab requirements

Blood counts

Hb ≥10 g/dL, ANC ≥1,000/µL, platelets ≥100,000/µL

Kidney function

creatinine clearance >50 mL/min as assessed by Cockcroft-Gault equation

Liver function

serum bilirubin ≤.5x ULN (unless known Gilbert's disease), AST and ALT ≤3x ULN

Cardiac function

Left ventricular ejection fraction > 50%

Adequate organ function: (Hb ≥10 g/dL, ANC ≥1,000/µL3, and platelets ≥100,000/µL3), serum bilirubin ≤.5x ULN (unless known Gilbert's disease), AST and ALT ≤3x ULN, and creatinine clearance >50 mL/min as assessed by Cockcroft-Gault equation. Left ventricular ejection fraction > 50%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Chao Family Comprehensive Cancer Center University of California, Irvine · Orange, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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