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).
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|ClinicalTrials.gov Identifier: NCT04429087|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : December 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Small Cell Lung Carcinoma and Other Neoplasms||Drug: BI 764532||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A First -in Human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Repeated Intravenous Infusions in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3|
|Actual Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||April 1, 2024|
|Estimated Study Completion Date :||April 1, 2024|
|Experimental: BI 764532||
Drug: BI 764532
- Maximum tolerated dose (MTD) [ Time Frame: up to 36 months ]Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.
- Number of patients with DLTs in the MTD evaluation period [ Time Frame: up to 36 months ]
- Cmax: maximum measured concentration of BI 764532 [ Time Frame: up to 36 months ]
- AUCτ: area under the concentration-time curve of the analyte over a uniform dosing interval τ [ Time Frame: up to 36 months ]
- Objective response based on RECIST 1.1 criteria in patients with measurable disease [ Time Frame: up to 36 months ]Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429087
|Contact: Boehringer Ingelheimemail@example.com|
|United States, Georgia|
|Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Mehmet Akce +001 404-778-1900 firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Daniel Morgensztern +001 (203) 737-4512 email@example.com|
|Universitätsklinikum Carl Gustav Carus Dresden||Recruiting|
|Dresden, Germany, 01307|
|Contact: Martin Wermke +49 (351) 45815624 firstname.lastname@example.org|
|Würzburg, Germany, 97080|
|Contact: Cyrus Sayehli +49 (931) 2010 email@example.com|
|National Cancer Center Hospital East||Recruiting|
|Chiba, Kashiwa, Japan, 277-8577|
|Contact: Yasutoshi Kuboki +81 47 1331111 firstname.lastname@example.org|
|Hospital Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Enriqueta Felip +34932746077 email@example.com|
|Hospital Clínico de Valencia||Recruiting|
|Valencia, Spain, 46010|
|Contact: Valentina Gambardella +34961973531 firstname.lastname@example.org|