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Obrixtamig

Phase 1

Small Cell Lung Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Obrixtamig · 1 trial · 4 indications

Phase 1 1
NCT07707895DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine CancersSmall Cell Lung Cancer
NOT YET_RECRUITING60 Analytics
PHASE1NOT YET_RECRUITING
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
6 weeks from the first administration of study medication.
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
Up to 24 months.
Part 2: PFS rate at 6 months
At 6 months.

Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.

Secondary Endpoints

Part 1 and Part 2: Occurrence of treatment-emergent DLTs
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
Up to 24 months.
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
Up to 24 months.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: obrixtamig + ZL-1310 (dosing regimen 1)EXPERIMENTAL -
Part 1: obrixtamig + ZL-1310 (dosing regimen 2)EXPERIMENTAL -
Part 2: obrixtamig + ZL-1310 + atezolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
ObrixtamigDRUGObrixtamig
ZL-1310DRUGZL-1310
AtezolizumabDRUGAtezolizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion criteria: For Part 1 1. Diagnosed with locally advanced, metastatic or relapsed cancer of the following histologies: * Small cell lung carcinoma (SCLC) * Large cell neuroendocrine lung carcinoma (LCNEC-L) * Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell ...

Countries:United StatesAustraliaBelgiumChinaFranceGermanyJapanNetherlandsPolandSpainUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07707895startDate: changed
LOWSep 2, 2026NCT07707895startDate: changed
LOWSep 2, 2026NCT07707895startDate: changed
LOWAug 20, 2026NCT07707895startDate: changed
LOWAug 20, 2026NCT07707895startDate: changed
LOWAug 20, 2026NCT07707895startDate: changed
LOWAug 20, 2026NCT07707895startDate: changed
LOWAug 5, 2026NCT07707895lastUpdatePostDate: changed
LOWJul 24, 2026NCT07707895lastUpdatePostDate: changed
LOWJul 24, 2026NCT07707895lastUpdatePostDate: changed
LOWJul 17, 2026NCT07707895NEW_TRIAL: changed
LOWJul 17, 2026NCT07707895NEW_TRIAL: changed
LOWJul 17, 2026NCT07707895NEW_TRIAL: changed

Frequently asked questions about Obrixtamig

What is Obrixtamig used for in Small Cell Lung Cancer?

Obrixtamig is an investigational small molecule being studied for the treatment of advanced Small Cell Lung Cancer and other neuroendocrine cancers. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in combination with another investigational agent, ZL-1310.

Who makes Obrixtamig?

Obrixtamig is being developed by Zai Lab Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ZLAB. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with advanced Small Cell Lung Cancer and other neuroendocrine cancers.

What phase is Obrixtamig in?

Obrixtamig is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the drug in combination with ZL-1310 in patients with advanced Small Cell Lung Cancer or other neuroendocrine cancers.

What clinical trials is Obrixtamig in?

Obrixtamig is being studied in a single Phase 1 clinical trial with the identifier NCT07707895, known as DAREON-36. This trial is evaluating Obrixtamig in combination with ZL-1310 in approximately 60 patients with advanced Small Cell Lung Cancer or other neuroendocrine cancers. The trial is not yet recruiting participants.

Is Obrixtamig the same as ZL-1310?

No, Obrixtamig and ZL-1310 are two different investigational drugs. The Phase 1 clinical trial NCT07707895 is testing Obrixtamig in combination with ZL-1310, meaning the two agents are being studied together. Obrixtamig is a small molecule developed by Zai Lab Limited, while ZL-1310 is a separate investigational compound.