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A Study of ZL-1310 in Participants With Selected Solid Tumors

{ "A Study of ZL-1310 for Solid Tumors", "This study is testing a drug called ZL-1310 in people with certain solid tumors. ZL-1310 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. You might be able to join if you are an adult (18 or older) with locally advanced or metastatic neuroendocrine carcinoma (NEC) that has been confirmed by a biopsy. You'll also need to provide a tumor tissue sample or be willing to have a new biopsy. The study will look at how safe ZL-1310 is and how well it shrinks tumors over a period of up to 36 months. The current recruitment status is unclear.", "design": "This is an open-label, multi-center study, meaning both you and your doctors will know you are receiving ZL-1310. It plans to enroll 166 participants.", "commitments": "You would receive ZL-1310 intravenously (through a vein) every 21 days. The study will monitor for side effects and tumor response for up to 36 months.", "compensation": "Not stated in the trial record.", "follow_up": "The study will track your safety and tumor response for up to 36 months.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06885281

A Study of ZL-1310 in Participants With Selected Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Zai Lab (Shanghai) Co., Ltd.
~166 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ZL-1310

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment Emergent Adverse-Events in Phase 1b
Measured over up to 36 months
+2 more outcomes measured

Conditions

Solid Tumors

Explore related trials

Neuroendocrine Carcinoma

NCT06885281

Where you'd take part

This study runs at 23 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Beijing Gobroad Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, Chinano site contact published

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, Chinano site contact published

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, Chinano site contact published

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, Chinano site contact published

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

ZaiLab_1310-002_StudyTeam
[email protected]
6503601601
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Treatment Emergent Adverse-Events in Phase 1bup to 36 months

    Number of subjects with treatment-emergent adverse events (TEAEs)

  • Incidence of Serious Adverse Events in Phase 1bup to 36 months

    Number of subjects with serious adverse events (SAEs)

  • Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2up to 36 months

    Confirmed objective response rate (ORR) determined by blinded independent central review (BICR) in Phase 2