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ZL-1310 for selected advanced solid tumors

A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors

Phase1; Phase2 Interventional Zai Lab (Hong Kong), Ltd. · NCT06885281

This will try the drug ZL-1310 in adults with selected advanced or metastatic solid tumors, especially neuroendocrine carcinomas that have progressed after platinum-based chemotherapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment112 (estimated)
Ages18 Years and up
SexAll
SponsorZai Lab (Hong Kong), Ltd. Industry-sponsored
Drugs / interventionsradiation
Locations21 sites (San Francisco, California and 20 other locations)
Trial IDNCT06885281 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1b/2 study gives ZL-1310 to adults with selected advanced or metastatic solid tumors to characterize safety, tolerability, and preliminary anti-tumor activity. Participants must have measurable disease, ECOG performance status 0–1, life expectancy of at least three months, and must provide a tumor biopsy or archived tissue. Key exclusions include clinically active CNS or leptomeningeal metastases, another progressing malignancy requiring treatment within the past two years, prior treatment with antibody-drug conjugates carrying topoisomerase I payloads, and recent systemic anti-cancer therapy. The trial is run at multiple Zai Lab sites in the United States and follows a Phase 1b/2 design with dose-finding and expansion elements.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic neuroendocrine carcinomas or other selected solid tumors who progressed after platinum-based therapy, have at least one measurable lesion, ECOG 0–1, and can provide tumor tissue for testing.

Not a fit: Patients with active central nervous system or leptomeningeal metastases, another progressing malignancy that requires treatment, prior exposure to ADCs with topoisomerase I payloads, or poor performance status (ECOG ≥2) are unlikely to benefit.

Why it matters

Potential benefit: If successful, ZL-1310 could provide a new treatment option that shrinks tumors or controls disease in patients whose cancers no longer respond to platinum chemotherapy.

How similar studies have performed: Similar antibody-drug conjugates delivering topoisomerase I inhibitors have shown activity in several solid tumors, so the approach has clinical precedent even though ZL-1310 itself is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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), 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:

* 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 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 this trial is running

San Francisco, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.