OncoMatch/Clinical Trials/NCT07064018
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Is NCT07064018 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Spedox-6 and Pegfilgrastim for soft-tissue sarcoma.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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 →Frequently asked questions
Is NCT07064018 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior doxorubicin or anthracycline equivalent disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify