NCT03319940

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Detailed description

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)

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Tarlatamab	Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
DRUG	Pembrolizumab	Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
DRUG	CRS Mitigation Strategies	Participants will be treated with one of the CRS mitigation strategies.

Timeline

• Start date: 2017-12-26
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2017-10-24
• Last updated: 2025-11-19

Locations

39 sites across 13 countries: United States, Australia, Austria, France, Germany, Hong Kong, Japan, Netherlands, Poland, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study