Clinical Trials List
Protocol Number1438-0005
NCT Number(ClinicalTrials.gov Identfier)NCT05882058
2023-11-01 - 2025-12-31
Phase II
Not yet recruiting3
DAREON™-5: An open-label, multi-center Phase II dose selection trial of intravenous BI 764532, a DLL3-targeting T cell engager, in patients with relapsed/refractory extensive-stage small cell lung cancer and in patients with other relapsed/refractory neuroendocrine carcinomas
-
Trial Applicant
Boehringer Ingelheim
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 蕭慈慧 無
- Yi-Ping Hung 無
- Yuh-Min Chen 無
- 趙恒勝 無
- Yung-Hung Luo 無
- YEN-HAN TSENG 無
- Hsu-ching Huang 無
- Chia-I Shen 無
- Ming-Huang Chen 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 張境夫 無
- 柯皓文 無
- Chih-Hung Chen 無
- Ping-Chih Hsu 無
- Cheng-Ta Yang 無
- 黃宗楨 無
- Chien-Ying Liu 無
- 枋岳甫 無
- Chih-Liang Wang 無
- 吳教恩 無
- 林定佑 無
- 邱立忠 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Small Cell Lung Carcinoma 、Neuroendocrine Neoplasms
Objectives
The trial's primary objectives are patients with SCLC who have progressed or relapsed after at least two prior lines of therapy, including at least one platinum-containing regimen, and patients with histologically or cytologically confirmed advanced or metastatic epNEC (excluding MCC). , MTC and NEPC) or lung LCNEC (as defined by the 2022 World Health Organization Classification of Neuroendocrine Tumors) who have progressed or relapsed after receiving at least one platinum-containing regimen, two dose levels of BI 764532 monotherapy were evaluated. Safety and effectiveness.
Secondary objectives are to further evaluate the efficacy of BI 764532 monotherapy; explore the impact of BI 764532 on core patient-reported outcomes (PROs); and further evaluate the safety and tolerability of BI 764532 monotherapy.
Test Drug
BI 764532
Active Ingredient
BI 764532
Dosage Form
Powder for Concentrate for Infusion
Dosage
10mg/vial
Endpoints
The main indicators of the test are
‧Objective response (OR), defined as the time from the date of treatment initiation until the earliest date of disease progression, death, or the last evaluable tumor assessment, loss of Best overall response as confirmed complete response (CR) or confirmed partial response (PR) at time of follow-up or withdrawal of consent.
‧Treatment-emergent adverse events (TEAEs).
‧Objective response (OR), defined as the time from the date of treatment initiation until the earliest date of disease progression, death, or the last evaluable tumor assessment, loss of Best overall response as confirmed complete response (CR) or confirmed partial response (PR) at time of follow-up or withdrawal of consent.
‧Treatment-emergent adverse events (TEAEs).
Inclution Criteria
Patients eligible for this trial have one of the following diagnoses:
‧Histologically or cytologically confirmed SCLC with a record of progression or recurrence after at least two previous lines of therapy, including at least one platinum-containing regimen
‧Histologically or cytologically confirmed epNEC (except patients with MCC, MTC, and NEPC) or pulmonary LCNEC with documented progression or recurrence after receiving at least one platinum-containing regimen
Main inclusion criteria
‧Age: Male or female participants aged 18 years and above the national legal age of consent at the time of signing the Informed Consent Form (ICF).
‧Before being allowed to enter this trial, a written informed consent must be signed and dated in accordance with the International Conference on Medical Regulations Good Clinical Practice (ICH-GCP) and local laws.
‧Cancer confirmed by histology or cytology with the following histology:
o SCLC
o epNEC (except MCC, MTC and NEPC)
o Lung LCNEC
Patients with tumors with any of the above types of mixed histology were eligible only if the neuroendocrine carcinoma/small tumor cell component was dominant and comprised at least 50% of the total tumor tissue.
The patient must have worsened or relapsed after standard of care therapy
o SCLC: After at least two prior lines of therapy, including at least one platinum-containing regimen
o epNEC/LCNEC: after receiving at least one platinum-containing regimen
‧East Coast Collaborative Cancer Group (ECOG) score of 0 or 1.
‧Measurable lesions as defined by RECIST version 1.1 within 21 days before the first dose of BI 764532.
‧Availability of stocked tumor tissue specimens.
‧Adequate organ function based on laboratory test values
‧All toxicities associated with prior anticancer therapy have resolved to CTCAE grade 1 (alopecia and peripheral neuropathy must be CTCAE grade 2, and amenorrhea/menorrhagia can be any grade) prior to administration of investigational treatment.
‧Histologically or cytologically confirmed SCLC with a record of progression or recurrence after at least two previous lines of therapy, including at least one platinum-containing regimen
‧Histologically or cytologically confirmed epNEC (except patients with MCC, MTC, and NEPC) or pulmonary LCNEC with documented progression or recurrence after receiving at least one platinum-containing regimen
Main inclusion criteria
‧Age: Male or female participants aged 18 years and above the national legal age of consent at the time of signing the Informed Consent Form (ICF).
‧Before being allowed to enter this trial, a written informed consent must be signed and dated in accordance with the International Conference on Medical Regulations Good Clinical Practice (ICH-GCP) and local laws.
‧Cancer confirmed by histology or cytology with the following histology:
o SCLC
o epNEC (except MCC, MTC and NEPC)
o Lung LCNEC
Patients with tumors with any of the above types of mixed histology were eligible only if the neuroendocrine carcinoma/small tumor cell component was dominant and comprised at least 50% of the total tumor tissue.
The patient must have worsened or relapsed after standard of care therapy
o SCLC: After at least two prior lines of therapy, including at least one platinum-containing regimen
o epNEC/LCNEC: after receiving at least one platinum-containing regimen
‧East Coast Collaborative Cancer Group (ECOG) score of 0 or 1.
‧Measurable lesions as defined by RECIST version 1.1 within 21 days before the first dose of BI 764532.
‧Availability of stocked tumor tissue specimens.
‧Adequate organ function based on laboratory test values
‧All toxicities associated with prior anticancer therapy have resolved to CTCAE grade 1 (alopecia and peripheral neuropathy must be CTCAE grade 2, and amenorrhea/menorrhagia can be any grade) prior to administration of investigational treatment.
Exclusion Criteria
Main exclusions
‧Untreated or symptomatic brain metastases. Participants with treated and stable brain metastases are eligible if they meet the following criteria:
o Radiation therapy or surgery for brain metastases should be completed at least 2 weeks before the first dose of BI 764532.
o The patient is off steroids for at least 7 days (physiologic doses of steroids are allowed), and the patient is off antiepileptic drugs for at least 7 days or on a stable dose of antiepileptic drugs for malignant central nervous system (CNS) disease.
‧Presence of leptomeningeal disease.
‧Activity/history of interstitial lung disease or non-infectious pneumonia (any grade).
‧Participants who experienced serious, life-threatening immune-mediated adverse events or infusion-related reactions while receiving immuno-oncology drugs that resulted in permanent discontinuation.
‧Previously received anti-cancer therapy:
o Patients who have received any other anticancer drug within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of BI 764532.
o Patients who have received extensive radiation therapy including whole brain irradiation within 2 weeks before the first dose of BI 764532.
‧Prior treatment with DLL3-targeted therapies, such as T-cell engagers.
‧Diagnosed immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of BI 764532. Physiological replacement of steroids is allowed.
‧Unresolved toxicities from previous anti-tumor therapies as defined in the trial protocol.
‧Major surgery (assessed as major by the trial moderator), such as hip replacement, performed within 28 days before randomization or planned during treatment.
‧Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening (other than the target indication), except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
‧Active infection requiring systemic drug therapy or other clinically significant intervention measures.
‧Laboratory evidence of any of the following hepatitis virus infections:
o Hepatitis B surface (HBs) antigen positive result
o Hepatitis B core (HBc) antibodies and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) are present simultaneously
o Presence of hepatitis C ribonucleic acid (RNA)
‧Patients with a known history of human immunodeficiency virus (HIV) infection who meet one or more of the following conditions:
o CD4+ count <350 cells/μL
o Viral load > 400 copies/μL (local laboratory assessment)
o Not receiving antiretroviral therapy
o Received less than 4 weeks of established antiretroviral therapy before initiation of trial treatment
o History of acquired immunodeficiency syndrome-definition (AIDS) opportunistic infection within 12 months before initiation of trial treatment
Patients with a history of HIV who do not meet any of the above criteria are eligible to participate, but patients must be under the care of an HIV/infectious disease specialist or must consult an HIV/infectious disease specialist before inclusion.
‧Known allergy to the trial drug or its excipients or, in the judgment of the trial moderator, a risk of allergy or allergic reaction to the drug product (e.g., history of allergic reaction or inability to take non-steroidal anti-inflammatory drugs (NSAIDs), inhalation Corticosteroids or equivalent prednisone at ?10 mg/day in patients with controlled autoimmune disease).
‧Severe cardiovascular/cerebrovascular disease (such as uncontrolled hypertension, unstable angina, history of infarction within the past 6 months, congestive heart failure >NYHA II).
‧Mean resting corrected QT interval (QTcF): >470 msec in women or >450 msec in men.
‧Untreated or symptomatic brain metastases. Participants with treated and stable brain metastases are eligible if they meet the following criteria:
o Radiation therapy or surgery for brain metastases should be completed at least 2 weeks before the first dose of BI 764532.
o The patient is off steroids for at least 7 days (physiologic doses of steroids are allowed), and the patient is off antiepileptic drugs for at least 7 days or on a stable dose of antiepileptic drugs for malignant central nervous system (CNS) disease.
‧Presence of leptomeningeal disease.
‧Activity/history of interstitial lung disease or non-infectious pneumonia (any grade).
‧Participants who experienced serious, life-threatening immune-mediated adverse events or infusion-related reactions while receiving immuno-oncology drugs that resulted in permanent discontinuation.
‧Previously received anti-cancer therapy:
o Patients who have received any other anticancer drug within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of BI 764532.
o Patients who have received extensive radiation therapy including whole brain irradiation within 2 weeks before the first dose of BI 764532.
‧Prior treatment with DLL3-targeted therapies, such as T-cell engagers.
‧Diagnosed immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of BI 764532. Physiological replacement of steroids is allowed.
‧Unresolved toxicities from previous anti-tumor therapies as defined in the trial protocol.
‧Major surgery (assessed as major by the trial moderator), such as hip replacement, performed within 28 days before randomization or planned during treatment.
‧Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening (other than the target indication), except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
‧Active infection requiring systemic drug therapy or other clinically significant intervention measures.
‧Laboratory evidence of any of the following hepatitis virus infections:
o Hepatitis B surface (HBs) antigen positive result
o Hepatitis B core (HBc) antibodies and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) are present simultaneously
o Presence of hepatitis C ribonucleic acid (RNA)
‧Patients with a known history of human immunodeficiency virus (HIV) infection who meet one or more of the following conditions:
o CD4+ count <350 cells/μL
o Viral load > 400 copies/μL (local laboratory assessment)
o Not receiving antiretroviral therapy
o Received less than 4 weeks of established antiretroviral therapy before initiation of trial treatment
o History of acquired immunodeficiency syndrome-definition (AIDS) opportunistic infection within 12 months before initiation of trial treatment
Patients with a history of HIV who do not meet any of the above criteria are eligible to participate, but patients must be under the care of an HIV/infectious disease specialist or must consult an HIV/infectious disease specialist before inclusion.
‧Known allergy to the trial drug or its excipients or, in the judgment of the trial moderator, a risk of allergy or allergic reaction to the drug product (e.g., history of allergic reaction or inability to take non-steroidal anti-inflammatory drugs (NSAIDs), inhalation Corticosteroids or equivalent prednisone at ?10 mg/day in patients with controlled autoimmune disease).
‧Severe cardiovascular/cerebrovascular disease (such as uncontrolled hypertension, unstable angina, history of infarction within the past 6 months, congestive heart failure >NYHA II).
‧Mean resting corrected QT interval (QTcF): >470 msec in women or >450 msec in men.
The Estimated Number of Participants
-
Taiwan
6 participants
-
Global
120 participants
