A First- in- human Phase I, non- randomized, open- label, multi- center dose escalation trial of BI 764532 administered by parenteral route in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3
A study to test different doses of BI 764532 in patients with small cell lung cancer and other neuroendocrine tumours that are positive for DLL3.
Tahara Eriko
Nippon Boehringer Ingelheim Co., Ltd.
2-1-1 Osaki, Shinagawa-ku, Tokyo
+81-120-189-779
medchiken.jp@boehringer-ingelheim.com
Kawahara Shizuko
Nippon Boehringer Ingelheim Co., Ltd.
2-1-1 Osaki, Shinagawa-ku, Tokyo
+81-120-189-779
medchiken.jp@boehringer-ingelheim.com
suspended
Sept. 07, 2020
34
Interventional
Open label trial with a dose finding phase
treatment purpose
1
* Signed and dated, written informed consent form (ICF2) in accordance with ICH-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 in-study biopsy) according to central pathology review in order to start BI 764532.
* 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.
* For back-fill cohorts only: patient has agreed to and signed an IC to provide pre-treatment and on-treatment fresh tumor biopsy (fresh pre- and on-treatment biopsies are optional for main dose escalation patients).
* At least one evaluable lesion outside of CNS as defined per modified RECIST 1.1.
* Adequate liver, bone marrow and renal organ function
* Previous treatment with T cells engagers or cell therapies targeting 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 <= CTCAE Grade1 (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.
* 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.
18age old over
No limit
Both
Small cell lung carcinoma and neuroendocrine carcinoma
investigational material(s)
Generic name etc : BI 764532
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous infusion, subcutaneous injection
safety
Maximum tolerated dose (MTD) in any studied regimen
safety
Number of patients with DLTs in the MTD evaluation period
pharmacokinetics
The following PK parameters of BI 764532 after the first and after multiple administrations of BI 764532 in all Regimens:
- Cmax: maximum measured concentration of BI 764532
- AUCtau: (area under the concentration-time curve of the analyte over a uniform dosing interval tau)
efficacy
Objective response based on RECIST 1.1 criteria in patients with measurable disease
