NCT06885281 · Zai Lab (Shanghai) Co., Ltd.
A Study of ZL-1310 in Participants With Selected Solid Tumors
What this study is about
A Phase Ib/II, where both patients and doctors know the treatment given, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
View original scientific description
A Phase Ib/II, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Interventions
DRUG
ZL-1310
drug ZL-1310
Primary outcome measures
Incidence of Treatment Emergent Adverse-Events in Phase 1b
Time frame: up to 36 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Incidence of Serious Adverse Events in Phase 1b
Time frame: up to 36 months
Number of subjects with serious adverse events (SAEs)
Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2
Time frame: up to 36 months
Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- San Francisco, California
- Peoria, Illinois
- Detroit, Michigan
- New York, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
- Houston, Texas
- McAllen, Texas
- Fairfax, Virginia
- Norfolk, Virginia
Collaborators
Zai Lab (US) LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations