Informations générales (source: ClinicalTrials.gov)

NCT06760819 En recrutement IDF
A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations
Interventional
  • Tumeurs des voies biliaires
  • Tumeurs de la vessie urinaire
  • Tumeurs du sein
  • Tumeurs du col de l'utérus
  • Tumeurs de l'oesophage
  • Tumeurs de la vésicule biliaire
  • Tumeurs gastro-intestinales
  • Tumeurs
  • Tumeurs de l'ovaire
  • Tumeurs du pancréas
  • Sarcomes
  • Tumeurs de l'estomac
  • Tumeurs colorectales
  • Tumeurs de l'endomètre
  • Tumeurs stromales gastro-intestinales
Phase 2
Bayer (Voir sur ClinicalTrials)
février 2025
octobre 2027
13 mai 2026
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Antoine HOLLEBECQUE En recrutement IDF 13/05/2026 15:25:06  Contacter

Critères

Tous


- Documented histologically or cytologically confirmed locally advanced, unresectable
or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer;
bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast
cancer; other solid tumor cancer, excluding NSCLC)

- Participant must be ≥18 years of age or over the legal age of consent

- Patients who have received prior standard therapy appropriate for their tumor type
and stage of disease, or who have no satisfactory alternative treatments

- Documented activating HER2 mutation

- At least one measurable lesion that would qualify as a target lesion by RECIST 1.1
criteria

Exclusion Criteria:


- Primary diagnosis of non-small cell lung cancer (NSCLC)

- Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)

- Active brain metastases

- Uncontrolled, severe, intercurrent illness