Subcutaneous Tarlatamab in Participants with Advanced Stage Small Cell Lung Cancer (DeLLphi-308)

Descrizione riassuntiva dello studio

This is an early clinical study to understand how participants tolerate and respond to different doses of SC Tarlatamab. This study is being conducted at multiple hospitals and is an open-label study, meaning both the researchers and participants know which treatment is being administered. Participants in this study suffer from advanced SCLC, which has either recurred or continued to grow after at least one prior SCLC treatment. The researchers' goal is to understand whether SC Tarlatamab is safe and well-tolerated, how the body responds to it, whether it can trigger the development of antibodies (an immune response), and slow cancer growth. The study includes three main phases: screening, treatment, and follow-up. During the follow-up, participants will no longer receive SC Tarlatamab but will undergo a safety check, followed by a long-term observation period. Participants will be included either in Part 1, where different doses of SC Tarlatamab are tested, or in Part 2, where the dose chosen in Part 1 is further investigated. A maximum of 100 participants can participate in both parts of the study (up to 60 participants in Part 1 and 40 participants in Part 2).

(BASEC)

Intervento studiato

Tarlatamab is a special protein that binds to specific target cells and prompts the immune system to kill cancer cells. The subcutaneous injections in Part 1 are administered in the abdomen, and in Part 2 either in the abdomen or in the thigh.

In both parts, participants are monitored in the hospital for 24 hours after the first two SC Tarlatamab injections. After the third SC Tarlatamab injection, participants will be observed for a period of 6 to 8 hours, and after the fourth and fifth SC Tarlatamab injections for a period of 6 hours.

(BASEC)

Malattie studiate

Small Cell Lung Cancer (SCLC) is a type of cancer that originates in the lung. Small Cell Lung Cancer can grow very rapidly, and there is a high risk that it will spread to other parts of the body. Researchers are investigating a drug called Tarlatamab, which is administered to participants with SCLC who have already been treated for SCLC, via an injection just under the skin (subcutaneous; SC). Tarlatamab targets a protein found in SCLC called delta-like ligand 3 (DLL3).

(BASEC)

Sponsor

Amgen Inc. Thousand Oaks, CA, USA Amgen Switzerland AG, Rotkreuz

(BASEC)

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

25.10.2024

(BASEC)

Risultati dello studio