Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
18 Years and older, Male and Female
20160323 (primary)
NCI-2017-02043
Summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with
SCLC
Objectives
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab
monotherapy, in combination with anti-PD1 therapy and with additional cytokine release
syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term
intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended
(HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Eligibility
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years old at the time of signing the informed consent
- Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with treated brain metastases are eligible provided they meet defined criteria
- Adequate organ function as defined in protocol
Treatment Sites in Georgia
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