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
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:
a. >14 days or >5 half-lives prior to study entry, whichever is shorter.
b. >14 days for radiotherapy. Note: A less than 1-week wash-out period is permitted only for palliative radiation to non-CNS disease with Sponsor approval.

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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