A Study on the Effect and Safety of BAY 2927088 Tablets in Patients with Solid Tumors and HER2 Mutations
Résumé de l'étude
Researchers are looking for a better way to treat people with solid tumors and HER2-activating mutations. Before a treatment can be approved for use in humans, researchers conduct clinical trials to better understand its safety and effectiveness. In this study, the researchers want to find out how well BAY2927088 works in people with different types of solid tumors with HER2 mutations. This includes tumors in the colon or rectum, the uterus and cervix (lower part of the uterus), the bladder, as well as the biliary tract (including gallbladder and bile ducts) and other types of solid tumors, except for people with advanced non-small cell lung cancer (NSCLC).
Solid tumors may have specific changes or mutations in a gene called human epidermal growth factor receptor 2 (HER2). This leads to the formation of an abnormal form of the HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is intended to block the abnormal HER2 protein, which may potentially stop the spread of cancer. The study will include about 111 participants who are at least 18 years old. All participants will take 20 mg of BAY2927088 in the form of tablets. Participants will receive treatments in 3-week periods, called cycles. These 3-week cycles will be repeated throughout the study. Participants may take BAY2927088 until their cancer worsens, they experience medical problems, or they withdraw from the study.
(BASEC)
Intervention étudiée
Adult participants with metastatic or unresectable solid tumors with HER-2-activating mutations, including: colorectal, biliary, bladder, cervical, endometrial, and other solid tumor types.
Participants will receive BAY2927088 20 mg twice daily (BID) until disease progression according to RECIST 1.1, unacceptable toxicity, or until another withdrawal criterion is met.
RECIST 1.1 = Criteria for evaluating response in solid tumors, version 1.1
BID: twice daily
(BASEC)
Maladie en cours d'investigation
various types of solid tumors with HER2 mutations
(BASEC)
- Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor disease (colorectal carcinoma; biliary tumor disease; bladder and urothelial tumor; cervical cancer; endometrial carcinoma; other solid tumor diseases, except for NSCLC).
- The participant must be ≥ 18 years old or have reached the legal minimum age for consent.
- Patients who have previously received an appropriate standard therapy for their tumor type and disease stage or for whom there are no satisfactory alternative treatments.
- Documented activating HER2 mutation.
- At least one measurable lesion that qualifies as a target lesion according to RECIST 1.1 criteria.
(BASEC)
Critères d'exclusion
- Primary diagnosis of non-small cell lung cancer (NSCLC).
- Previous treatment with a HER2 tyrosine kinase inhibitor (TKI).
- Active brain metastases.
- Uncontrolled, severe comorbid condition.
(BASEC)
Lieu de l’étude
Berne, Genève, Zurich
(BASEC)
Sponsor
Sophia Birnbaum Bayer (Schweiz) AG Medical Departement Bayer Schweiz, Pharmaceuticals Clinical Research Grubenstrasse 8 8045 Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Sophia Birnbaum
+41 44 465 81 11
clinical.operations.switzerland@clutterbayer.comBayer (Schweiz) AG Medical Departement Bayer Schweiz, Pharmaceuticals Clinical Research Grubenstrasse 8 8045 Zurich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
08.05.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
A Phase 2 open-label basket study to evaluate the efficacy and safety of orally administered reversible tyrosine kinase inhibitor BAY 2927088 (sevabertinib) in participants with metastatic or unresectable solid tumors with HER2-activating mutations (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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