A Study of ZL-1310 in Participants With Selected Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Solid Tumors
In brief
A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Key facts
- Study ID
- NCT06885281
- Run by
- Zai Lab (Shanghai) Co., Ltd.
- People needed
- 166
- Starts
- 2025-05-12
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Adult men and women ≥18 years of age
- Participants must have histologically confirmed, locally advanced or metastatic NeuroEndocrine Carcionomas (NEC)
- 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
You may not qualify if…
- Participants with another known malignancy that is progressing or requires active treatment within the last 2 years
- 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)or had received topoisomerase I inhibitor (e.g., irinotecan) as the immediate prior therapy that the participant had progressed from.
- 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
Where it is running
- Zai Lab Site 2001 — San Francisco, California, United States (enrolling)
- Zai Lab Site 2015 — Peoria, Illinois, United States (enrolling)
- Zai Lab Site 2013 — Detroit, Michigan, United States (enrolling)
- Zai Lab Site 2002 — New York, New York, United States (enrolling)
- Zai Lab Site 2024 — Cleveland, Ohio, United States (enrolling)
- Zai Lab Site 2004 — Philadelphia, Pennsylvania, United States (enrolling)
- Zai Lab Site 2014 — Nashville, Tennessee, United States (enrolling)
- Zai Lab Site 2003 — Dallas, Texas, United States (enrolling)
- Zai Lab Site 2007 — Houston, Texas, United States (enrolling)
- Zai Lab Site 2011 — McAllen, Texas, United States (enrolling)
- Zai Lab Site 2006 — Fairfax, Virginia, United States (enrolling)
- Zai Lab Site 2012 — Norfolk, Virginia, United States (enrolling)
- Zai Lab Site 1002 — Beijing, Beijing Municipality, China (enrolling)
- Zai Lab Site 1013 — Beijing, Beijing Municipality, China (enrolling)
- Zai Lab Site 1009 — Xiamen, Fujian, China (enrolling)
- Zai Lab Site 1016 — Guangzhou, Guangdong, China (enrolling)
- Zai Lab Site 1004 — Guangzhou, Guangdong, China (enrolling)
- Zai Lab Site 1012 — Harbin, Heilongjiang, China (enrolling)
- Zai Lab Site 1006 — Changsha, Hunan, China (enrolling)
- Zai Lab Site 1008 — Changchun, Jilin, China (enrolling)
- Zai Lab Site 1001 — Shanghai, Shanghai Municipality, China (enrolling)
- Zai Lab Site 1025 — Shanghai, Shanghai Municipality, China
- Zai Lab Site 1026 — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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