Lung Cancer Clinical Trial
A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).
To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE) and dosing regimen for further development of BI 764532. The MTDs will be defined based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period in studied regimens. The RDE will be guided by overall safety, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments.
Additional objectives are to document the safety and tolerability of BI 764532, to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals.
Phase Ib will further explore BI 764532 in selected patients populations based on data from phase Ia.
The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.
Signed and dated, written informed consent form (ICF2) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
Small cell lung carcinoma (SCLC)
Large cells neuroendocrine lung carcinoma(LCNEC)
Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start BI 764532
Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue.
For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Subjects with brain metastases are eligible provided they meet the following criteria:
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.
Adequate liver, bone marrow and renal organ function Futher inclusion criteria apply
Previous treatment with T cell Engager (TcE) or cell therapies targeting Delta-Like Ligand 3 (DLL3).
Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy).
Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.
Prior anti-cancer therapy:
Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.
Other active malignancy that could interfere with the prognosis and treatment of the disease of the study.
Major surgery within 28 days of first dose BI 764532.
Women who are pregnant, nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 3 months after the last dose of study treatment.
Active infection that requires medical therapy or other clinically significant intervention or within 2 weeks prior to study entry confirmed (PCR test or other applicable test as per local requirments) or suspected SARS-CoV-2 infection or close contact with an individual with confirmed SARS-CoV-2 infection.
Further exclusion criteria apply
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