A Study of ZL-1310 in Participants With Selected Solid Tumors
NCT ID: NCT06885281
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
112 participants
INTERVENTIONAL
2025-05-12
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
ZL-1310 as a single agent
ZL-1310
drug ZL-1310
Interventions
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ZL-1310
drug ZL-1310
Eligibility Criteria
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Inclusion Criteria
* Adult men and women ≥18 years of age
* Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC), and must have experienced disease progression on or after platinum-based therapy
* Participants must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample
* Participants must have at least one measurable target lesion as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥ 3 months
Exclusion Criteria
* Clinically active central nervous system (CNS) metastases
* Participants with leptomeningeal metastasis
* Participants who have received any ADC with a payload of topoisomerase I inhibitor (e.g., exatecan derivative)
* Treatment with any systemic anti-cancer treatment or other investigational products/device within 3 weeks before the first dose of study treatment
* Non-palliative radiotherapy within 2 weeks to non-thoracic area or within 4 weeks to the thoracic area prior to first dose of study treatment or a history of radiation pneumonitis
* Major surgery within 4 weeks of the first dose of study treatment
* Hypersensitivity to any ingredient of the study treatment
* Out of range value (as defined in protocol) within 10 days prior to the first dose of study treatment
* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
* Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders including but not limited to pneumonitis
* Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
* Pregnant or nursing (lactating) women
* Participants who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer
18 Years
ALL
No
Sponsors
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Zai Lab (US) LLC
INDUSTRY
Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zai Lab Site 2001
San Francisco, California, United States
Zai Lab Site 2002
New York, New York, United States
Zai Lab Site 2024
Cleveland, Ohio, United States
Zai Lab Site 2004
Philadelphia, Pennsylvania, United States
Zai Lab Site 2003
Dallas, Texas, United States
Zai Lab Site 2007
Houston, Texas, United States
Zai Lab Site 2006
Fairfax, Virginia, United States
Zai Lab Site 1002
Beijing, Beijing Municipality, China
Zai Lab Site 1013
Beijing, Beijing Municipality, China
Zai Lab Site 1009
Xiamen, Fujian, China
Zai Lab Site 1016
Guangzhou, Guangdong, China
Zai Lab Site 1004
Guangzhou, Guangdong, China
Zai Lab Site 1012
Harbin, Heilongjiang, China
Zai Lab Site 1006
Changsha, Hunan, China
Zai Lab Site 1008
Changchun, Jilin, China
Zai Lab Site 1001
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Site 2001
Role: primary
Site 2002
Role: primary
Site 2024
Role: primary
Site 2004
Role: primary
Site 2003
Role: primary
Site 2007
Role: primary
Site 2006
Role: primary
Site 1002
Role: primary
Site 1013
Role: primary
Site 1009
Role: primary
Site 1016
Role: primary
Site 1004
Role: primary
Site 1012
Role: primary
Site 1006
Role: primary
Site 1008
Role: primary
Site 1001
Role: primary
Other Identifiers
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ZL-1310-002
Identifier Type: -
Identifier Source: org_study_id
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