Trials / Recruiting
RecruitingNCT07064018
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
- Soft-tissue Sarcoma
- Triple Negative Breast Cancer
- Non-small Cell Lung Cancer
- Cervical Cancer
- Ovarian Cancer
- KRAS Mutation-Related Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spedox-6 | Given Intravenously (IV) |
| DRUG | Pegfilgrastim | Given Subcutaneous Injection or IV |
| DRUG | Filgrastim | Given Subcutaneous Injection or IV |
Timeline
- Start date
- 2025-04-30
- Primary completion
- 2029-12-31
- Completion
- 2031-12-31
- First posted
- 2025-07-14
- Last updated
- 2025-07-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07064018. Inclusion in this directory is not an endorsement.