RecruitingPhase 1Phase 2NCT07064018

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


Sponsor

University of California, Irvine

Enrollment

67 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests SPEDOX-6 (a new form of doxorubicin — a well-known chemotherapy drug — wrapped in a protein to improve delivery) in people with advanced solid tumors that have not responded to at least two previous treatments. **You may be eligible if...** - You are 18 years or older - You have a confirmed advanced solid tumor (including soft tissue sarcoma, triple-negative breast cancer, cervical cancer, non-small cell lung cancer, ovarian cancer, or KRAS-mutated pancreatic cancer) - Your cancer has come back or stopped responding to at least two prior treatment regimens - You have measurable disease on imaging - You are in good enough overall health (ECOG performance status 0–2) with at least 12 weeks expected survival **You may NOT be eligible if...** - You have not received at least two prior treatment regimens - Your organ function is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpedox-6

Given Intravenously (IV)

DRUGPegfilgrastim

Given Subcutaneous Injection or IV

DRUGFilgrastim

Given Subcutaneous Injection or IV


Locations(1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

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NCT07064018


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