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NCT07064018 · ClinicalTrials.gov registry record · Phase 1
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT07064018: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by University of California, Irvine.
NCT07064018 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 67 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07064018, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Conditions Studied
Interventions
- DRUG Filgrastim
- DRUG Spedox-6
- DRUG Pegfilgrastim
Study Locations (1)
California
- Chao Family Comprehensive Cancer Center University of California, Irvine - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2025-04-30 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 1 |
What NCT07064018 shows while recruiting
NCT07064018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Filgrastim is the first listed.
NCT07064018 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07064018 about?
NCT07064018 is a clinical study titled "Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies". 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 ...
What is the current status of trial NCT07064018?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2025-04-30. Estimated completion is 2031-12-31.
What conditions does trial NCT07064018 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Cervical Cancer, Triple Negative Breast Cancer, Soft Tissue Sarcoma.
What interventions are being tested in trial NCT07064018?
The interventions under investigation include: Filgrastim (DRUG), Spedox-6 (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT07064018?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07064018 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07064018's enrollment target sits among peer trials
67 298th of 454 higher than 155 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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