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.
Subjects ≥ 18 years at the first screening examination/visit.
Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies.
Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.
Disease that is considered measurable by RECIST v1.1.
Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.
Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
Untreated metastases to the Central Nervous System (CNS).
Have received any prior doxorubicin or anthracycline equivalent.
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Treatment groupsSee each treatment group below.
University of California, Irvine
Lead sponsor
Sunstate Biosciences LLC
Collaborator