University of California, Irvine
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.
Inclusion Criteria: * 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. * Eastern Cooperative Oncology Group (ECOG) performance status of 0…
Given Intravenously (IV)
Given Subcutaneous Injection or IV
Given Subcutaneous Injection or IV
Arctuva estimate
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