Subcutaneous Tarlatamab in Participants with Advanced Stage Small Cell Lung Cancer (DeLLphi-308)
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
The study will include men and women aged 18 years and older who have been diagnosed with advanced SCLC that has either recurred or continued to grow after at least one prior treatment. Participants must have adequate organ function and be in physical condition to tolerate the treatment. Participants must be able to receive subcutaneous injections of Tarlatamab in their abdomen or thigh, depending on which part of the study they are included in. Additional inclusion criteria apply according to the study protocol. (BASEC)
Critères d'exclusion
Participants must not have received prior DLL3-targeted treatment and must not have untreated or symptomatic SCLC that has spread to the brain. Pregnant women, breastfeeding women, or women planning a pregnancy are not allowed to participate in the study. Participants must not receive any other investigational drugs. Additional exclusion criteria apply according to the study protocol. (BASEC)
Lieu de l’étude
Chur, Fribourg, Winterthur
(BASEC)
Sponsor
Amgen Inc. Thousand Oaks, CA, USA Amgen Switzerland AG, Rotkreuz
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Laetitia Mauti
+41 52 266 23 73
Laetitia.Mauti@clutterksw.chKantonsspital Winterthur, Medizinische Onkologie
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
25.10.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Eine Phase-1b-Studie zur Beurteilung der Sicherheit, Verträglichkeit, Pharmakokinetik und vorläufigen antitumoralen Aktivität von Tarlatamab subkutan bei Teilnehmenden mit kleinzelligem Lungenkarzinom im fortgeschrittenen Stadium (DeLLphi-308) (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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