Allgemeine Informationen
  • Krankheitskategorie Dickdarm- und Mastdarmkrebs , Lungenkrebs , Melanom (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bellinzona, St Gallen
    (BASEC)
  • Studienverantwortliche Martina Imbimbo martina.imbimbo@eoc.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 12.05.2025 ICTRP: N/A
  • Letzte Aktualisierung 12.05.2025 16:10
HumRes66117 | SNCTP000006184 | BASEC2024-D0095

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.

  • Krankheitskategorie Dickdarm- und Mastdarmkrebs , Lungenkrebs , Melanom (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bellinzona, St Gallen
    (BASEC)
  • Studienverantwortliche Martina Imbimbo martina.imbimbo@eoc.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 12.05.2025 ICTRP: N/A
  • Letzte Aktualisierung 12.05.2025 16:10

Zusammenfassung der Studie

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)

Untersuchte Intervention

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)

Untersuchte Krankheit(en)

The study involves the treatment of patients with advanced solid tumors, including non-small cell lung cancer, colorectal cancer, gastric cancer, and melanoma.

(BASEC)

Kriterien zur Teilnahme
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)

Ausschlusskriterien
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)

Studienstandort

Bellinzona, St Gallen

(BASEC)

nicht verfügbar

Sponsor

AMGEN Switzerland

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Martina Imbimbo

+41 91 811 89 31

martina.imbimbo@eoc.ch

Ente Ospedaliero Cantonale (EOC) Istituto Oncologico della Svizzera italiana (IOSI)-Ospedale San Giovanni (ORBV), Via A. Gallino 12, CH-6500 Bellinzona

(BASEC)

Wissenschaftliche Auskünfte

nicht verfügbar

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Tessin

(BASEC)

Datum der Bewilligung durch die Ethikkommission

20.11.2024

(BASEC)


ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)

Wissenschaftlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie

Zusammenfassung der Ergebnisse

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Link zu den Ergebnissen im Primärregister

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