Small Cell Lung Cancer (SCLC) Clinical Trial
Official title:
A Phase 1/2 Open-label, Dose Escalation and Dose Expansion Study Designed to Evaluate the Safety, Tolerability, PharmacoKinetics, Pharmacodynamics and EfficacY of PT217 Bispecific Antibody in Patients With NeuRoendocrIne Carcinomas That May Benefit From Treating Their DLL3 expressinG CancEr.
PT217 is a bispecific antibody (bsAb) against human DLL3 (huDLL3) and human CD47 (huCD47). This is a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 in subjects with neuroendocrine carcinomas. Patients with the following tumor types will be eligible for screening: small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinoma (EP-NEC), including but not limited to neuroendocrine prostate cancer (NEPC) and gastroentero-pancreatic neuroendocrine carcinoma (GEP-NEC). Patients must have progressed after standard therapy (platinum-based chemotherapy) or standard therapy has proven to be ineffective, intolerable or is considered inappropriate.
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