DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Boehringer Ingelheim
Study ID
NCT07707895
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology
  • Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology
  • Large Cell Neuroendocrine Lung Carcinoma
  • Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer. In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein. The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

Key Dates

First listed
Jul 16, 2026
Start date
Sep 24, 2026
Status verified
Aug 2026
Primary completion
Apr 26, 2030
Completion
Apr 26, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 1)
  • Experimental: Part 1: obrixtamig + ZL-1310 (dosing regimen 2)
  • Experimental: Part 2: obrixtamig + ZL-1310 + atezolizumab

Primary Outcome Measure

Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period [ Time Frame: 6 weeks from the first administration of study medication. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Boehringer Ingelheim
[email protected]
833-602-2368
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612
Boehringer Ingelheim
[email protected]
833-602-2368
University of Kentucky Medical CenterLexingtonKentucky40536
Boehringer Ingelheim
[email protected]
833-602-2368

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MedStar Georgetown University Hospital· Washington D.C., DCH. Lee Moffitt Cancer Center and Research Institute· Tampa, FLUniversity of Kentucky Medical Center· Lexington, KY

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