Status:
RECRUITING
A Study of ZL-1310 in Participants With Selected Solid Tumors
Lead Sponsor:
Zai Lab (Shanghai) Co., Ltd.
Collaborating Sponsors:
Zai Lab (US) LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Detailed Description
This is an open-label, multiple-center, phase Ib/II study of ZL-1310 in selected solid tumors.
Eligibility Criteria
Inclusion
- Signed informed consent
- Adult men and women ≥18 years of age
- Participants must have histologically confirmed, locally advanced or metastatic NECs, 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
- 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)
- 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 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06885281
Start Date
May 12 2025
End Date
June 1 2027
Last Update
December 15 2025
Active Locations (16)
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1
Zai Lab Site 2001
San Francisco, California, United States, 94143
2
Zai Lab Site 2002
New York, New York, United States, 10065
3
Zai Lab Site 2024
Cleveland, Ohio, United States, 44106
4
Zai Lab Site 2004
Philadelphia, Pennsylvania, United States, 19111