A study to evaluate a new drug called AMG 355, administered alone or in combination with another drug, Pembrolizumab, in patients with advanced cancers, to assess its safety and efficacy.
Descrizione riassuntiva dello studio
This is a multicenter, open-label phase 1 study conducted in two treatment groups. In the first group, participants receive AMG 355 as monotherapy, and in the second group, AMG 355 is administered in combination with Pembrolizumab. The study consists of three parts: dose escalation, dose confirmation, and dose expansion, to characterize safety and preliminary efficacy in larger populations. Approximately 485 participants will be enrolled in the study.
(BASEC)
Intervento studiato
AMG 355 is a drug that aims to enhance the immune system by targeting certain immune cells in the tumor known as regulatory T cells. This may allow the immune system to act more actively against the cancer and fight it more effectively. Participants receive either AMG 355 as a single treatment or in combination with Pembrolizumab. The study is divided into three parts per treatment group: in the first part, the dose of AMG 355 is gradually increased to test its safety and tolerability. In the second and third parts, the optimal dose is confirmed and the efficacy of the drug is investigated in a larger group of patients with certain advanced cancers.
(BASEC)
Malattie studiate
The study involves the treatment of patients with advanced solid tumors, including non-small cell lung cancer, colorectal cancer, gastric cancer, and melanoma.
(BASEC)
Participants must be at least 18 years old and have histologically or cytologically confirmed metastatic or locally advanced solid tumors that have recurred and/or not responded to established and available therapies with known clinical benefit, or are unsuitable for these. This includes participants with non-small cell lung cancer (NSCLC), colorectal adenocarcinoma (CRC), gastric adenocarcinoma (GC), and melanoma. Patients with CRC must have microsatellite stable (MSS) disease. Participants must have an estimated life expectancy of at least 3 months, as assessed by the study physician, and an ECOG (Eastern Cooperative Oncology Group) status of 0 or 1. They must also be willing to undergo at least one biopsy. (BASEC)
Criteri di esclusione
Medical conditions or treatment histories that preclude participation in the study include, among others, untreated or symptomatic metastases in the central nervous system, prior T-cell receptor-targeted therapies that were discontinued due to immune-related side effects, known allergic reactions to antibody therapies, use of immunosuppressants, autoimmune diseases, active infections, prior organ transplants, as well as the use of certain medications that may interact with the study treatment. It is also important that patients do not participate simultaneously in another clinical trial. These criteria are designed to ensure that the study is as safe as possible for participants and that the results of the study are meaningful. (BASEC)
Luogo dello studio
Bellinzona, San Gallo
(BASEC)
Sponsor
AMGEN Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Martina Imbimbo
+41 91 811 89 31
martina.imbimbo@cluttereoc.chEnte Ospedaliero Cantonale (EOC) Istituto Oncologico della Svizzera italiana (IOSI)-Ospedale San Giovanni (ORBV), Via A. Gallino 12, CH-6500 Bellinzona
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
20.11.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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