BI 764532
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Technische Universitaet Dresden, Boehringer Ingelheim
Conditions
Extra-pulmonary neuroendocrine carcinomaExtrapulmonary neuroendocrine carcinoma of large cell histologyExtrapulmonary neuroendocrine carcinoma of small cell histologyGliomaLarge cell neuroendocrine carcinomaLarge cell neuroendocrine lung carcinomaMale and female adult patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung not eligible for curative treatmentNeuroendocrine Neoplasms
Phase 1
A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3
RecruitingNCT05916313
Start: 2024-01-30End: 2027-09-30Target: 20Updated: 2026-10-27
A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer
RecruitingNCT05963867
Start: 2024-08-06End: 2027-01-15Target: 12Updated: 2026-10-14
DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With a Single Agent Chemotherapy
Active, not recruitingNCT05990738
Start: 2024-02-14End: 2027-04-30Updated: 2026-09-15
DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
Active, not recruitingNCT06077500
Start: 2024-02-14End: 2027-04-01Updated: 2026-10-27
DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
Active, not recruitingNCT06132113
Start: 2024-01-22End: 2027-12-31Updated: 2026-10-06
A Phase Ib/II, open-label, safety and tolerability trial of obrixtamig in combination with ZL-1310 in patients with poorly differentiated NEC
Not yet recruitingCTIS2026-525634-27-00
Target: 26Updated: 2026-10-06
A Phase Ib/II, open-label, safety and tolerability trial of intravenous obrixtamig in combination with pumitamig and standard of care (carboplatin, etoposide) in patients with extensive stage small cell lung carcinoma.
Not yet recruitingCTIS2026-525459-99-00
Target: 12Updated: 2026-10-27
Phase 2
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
RecruitingCTIS2023-504247-13-00
Start: 2023-10-17Target: 100Updated: 2025-12-29
A Phase II, single-arm trial on the addition of the DLL3xCD3 bispecific T-cell engager obrixtamig (BI 764532) to standard-of-care platinum-based first-line treatment of advanced large-cell neuroendocrine carcinoma of the lung (ALPINE 2)
Not yet recruitingCTIS2025-524345-28-00
Target: 75Updated: 2026-08-31
Phase 3
DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.
Not yet recruitingCTIS2025-520565-51-00
Target: 105Updated: 2026-05-13
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
Not yet recruitingCTIS2025-523869-22-00
Target: 86Updated: 2026-05-14