Studieoverzicht
Study name: A Phase I Study of Zenocutuzumab (MCLA-128), a Human IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumours (eNRGy trial)
Histology | NSCLC |
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Tumor stage | Stage I - III, Stage IV |
Host / recruiting sites | Antoni van Leeuwenhoek |
Enrollment | Recruiting |
Therapy line | Later line (≥2L) |
Design |
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single indication expansion group assignment study to assess the safety, tolerability, PK, PD, immunogenicity and antitumor activity of MCLA-128. T |
Intervention | MCLA-128 |
Key inclusion criteria | Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128: |
Key exclusion criteria | Presence of an active uncontrolled infection or an unexplained fever greater than 38.5°C during Screening up to the first scheduled day of dosing. At the discretion of the Investigator, patients with tumor fever or a clinically insignificant minor infection may be enrolled (i.e., mild upper respiratory infection) Known symptomatic or unstable brain metastases. Patients with asymptomatic brain metastases are eligible to participate if the metastases have been radiographically and clinically stable for at least one month. If on steroids for this indication, the patient must be on a stable dose for at least one month; |
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