This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.
The purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer.
The study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.
All participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment.
The first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.
Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Small cell lung cancer (SCLC)
Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))
Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.
Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.
Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.
Part 1: Active/previous history of interstitial lung disease or non-infectious pneumonitis (any grade).
Parallel
BI 764532, dose 1
DrugBI 764532, dose 1
BI 764532, dose 2
DrugBI 764532, dose 2
Ventana DLL3 RxDx assay
DeviceVentana DLL3 RxDx assay
Part 1: Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR)
according to RECIST v 1.1 by investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Part 1: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Part 2: Objective response (OR)
Objective response is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v 1.1 by blinded independent central review from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
Part 3: Occurrence of treatment-emergent adverse events (TEAEs) during the on-treatment period
Part 1: Duration of objective response (DOR) based on investigator assessment
DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR.
Part 1: Progression-free survival (PFS) based on investigator assessment
PFS is defined as the time from treatment start until the earliest date of tumour progression according RECIST v 1.1 or death from any cause, whichever occurs first.
Part 1: Disease control (DC), defined as best overall response of CR or PR or stable disease (SD) based on investigator assessment
where best overall response is defined according to RECIST v 1.1, from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
Part 1, 2, and 3: Overall survival (OS), defined as the time from treatment start until death from any cause
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