BI 1438-0001 - therapeutisch -

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 Recommended Dose for Expansion (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.

To determine the maximum tolerated dose(s) (MTD) or recommended dose for expansion (RDE) and dosing regimen for the advancement of BI 764532. MTDs will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD evaluation period in the regimens studied. The recommended dose for expansion (RDE) will be guided by assessments of overall safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD). Additional objectives include documenting the safety and tolerability of BI 764532, characterizing pharmacokinetics and pharmacodynamics, and evaluating efficacy signals. In Phase Ib, BI 764532 will be further investigated in selected patient populations based on data from Phase Ia. The objectives, endpoints and design of Phase Ib will be defined in an amendment to the study protocol once the results of Phase Ia are available.

{ "short_title": "BI 1438-0001 - therapeutisch -", "data_mode": "900", "data_mode_number": "000002042", "official_title": "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).", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": "NCT04429087", "eudract_number": "2019-000729-31", "general_contact_email": "ectu@ukdd.de", "general_contact_phone": "+49 351-4587566", "hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke", "description_laie_de": "Zur Bestimmung der maximal vertr\u00e4glichen Dosis(n) (MTD) oder der empfohlenen Dosis f\u00fcr die Expansion (RDE) und des Dosierungsschemas f\u00fcr die Weiterentwicklung von BI 764532. Die MTDs werden auf der Grundlage der H\u00e4ufigkeit der Patienten definiert, die w\u00e4hrend der MTD-Auswertungsperiode in den untersuchten Schemata dosisbegrenzende Toxizit\u00e4ten (DLTs) erfahren. Die empfohlene Dosis f\u00fcr die Ausdehnung (RDE) wird sich an den Bewertungen der allgemeinen Sicherheit, Wirksamkeit, Pharmakokinetik (PK) und Pharmakodynamik (PD) orientieren. Weitere Ziele sind die Dokumentation der Sicherheit und Vertr\u00e4glichkeit von BI 764532, die Charakterisierung von Pharmakokinetik und Pharmakodynamik sowie die Auswertung von Wirksamkeitssignalen. In Phase Ib wird BI 764532 an ausgew\u00e4hlten Patientenpopulationen auf der Grundlage von Daten aus Phase Ia weiter untersucht. Die Ziele, Endpunkte und das Design der Phase Ib werden in einer \u00c4nderung des Studienprotokolls nach Vorliegen der Ergebnisse der Phase Ia festgelegt.", "description_laie_en": "To determine the maximum tolerated dose(s) (MTD) or recommended dose for expansion (RDE) and dosing regimen for the advancement of BI 764532. MTDs will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD evaluation period in the regimens studied. The recommended dose for expansion (RDE) will be guided by assessments of overall safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD). Additional objectives include documenting the safety and tolerability of BI 764532, characterizing pharmacokinetics and pharmacodynamics, and evaluating efficacy signals. In Phase Ib, BI 764532 will be further investigated in selected patient populations based on data from Phase Ia. The objectives, endpoints and design of Phase Ib will be defined in an amendment to the study protocol once the results of Phase Ia are available.", "description_expert_de": "Zur Bestimmung der maximal vertr\u00e4glichen Dosis(n) (MTD) oder der empfohlenen Dosis f\u00fcr die Expansion (RDE) und des Dosierungsschemas f\u00fcr die Weiterentwicklung von BI 764532. Die MTDs werden auf der Grundlage der H\u00e4ufigkeit der Patienten definiert, die w\u00e4hrend der MTD-Auswertungsperiode in den untersuchten Schemata dosisbegrenzende Toxizit\u00e4ten (DLTs) erfahren. Die empfohlene Dosis f\u00fcr die Ausdehnung (RDE) wird sich an den Bewertungen der allgemeinen Sicherheit, Wirksamkeit, Pharmakokinetik (PK) und Pharmakodynamik (PD) orientieren. Weitere Ziele sind die Dokumentation der Sicherheit und Vertr\u00e4glichkeit von BI 764532, die Charakterisierung von Pharmakokinetik und Pharmakodynamik sowie die Auswertung von Wirksamkeitssignalen. In Phase Ib wird BI 764532 an ausgew\u00e4hlten Patientenpopulationen auf der Grundlage von Daten aus Phase Ia weiter untersucht. Die Ziele, Endpunkte und das Design der Phase Ib werden in einer \u00c4nderung des Studienprotokolls nach Vorliegen der Ergebnisse der Phase Ia festgelegt.", "description_expert_en": "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 Recommended Dose for Expansion (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.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I", "main_cat_id": 1, "sub_cat_id": 2 }

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