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NCT Number: NCT06885281

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

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

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zai Lab Site 1002, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors. ZL-1310 will be administered intravenously at 1.6 mg/kg every 21 days. Primary objectives include safety evaluation and confirmed objective response rate by blinded independent central review

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZL-1310

Drug

drug ZL-1310

Primary outcomes

  1. Incidence of Treatment Emergent Adverse-Events in Phase 1b

    Time frame: up to 36 months

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

  2. Incidence of Serious Adverse Events in Phase 1b

    Time frame: up to 36 months

    Number of subjects with serious adverse events (SAEs)

  3. 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

Secondary outcomes

  1. Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b

    Time frame: up to 36 months

    • BICR-determined confirmed ORR in all cohorts
    • Investigator-determined confirmed ORR in all cohorts
    • BICR-determined 6-months progression-free survival (PFS6) rate in Cohort 3
    • Investigator-determined PFS6-rate in Cohort 3

  2. Evaluate durability of response in Phase 1b

    Time frame: up to 36 months

    • BICR- and investigator-determined duration of response (DOR) in Phase 1b

  3. Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 2

    Time frame: up to 36 months

    Investigator-determined confirmed ORR in Phase 2

  4. Evaluate durability of response in Phase 2

    Time frame: up to 36 months

    • BICR- and investigator-determined duration of DOR in Phase 2

  5. Incidence of Treatment Emergent Adverse-Events in Phase 2

    Time frame: up to 36 months

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

  6. Incidence of Serious Adverse Events in Phase 2

    Time frame: up to 36 months

    Number of subjects with serious adverse events (SAEs)

  7. Pharmacokinetics (PK): Time to maximum concentration (Tmax) of Total Antibody in all phases

    Time frame: up to 36 months

    Time to maximum concentration (Tmax) is a pharmacokinetic parameter that refers to the time it takes for a drug or substance to reach its highest concentration in the bloodstream or a specific body compartment after administration

  8. Pharmacokinetics (PK): maximum concentration (Cmax) of Total Antibody in all phases

    Time frame: up to 36 months

    Maximum concentration (Cmax) is a key pharmacokinetic parameter. It represents the highest concentration of a drug or substance that is achieved in the bloodstream or a specific biological fluid or tissue after administration

  9. Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Total Antibody in all phases

    Time frame: up to 36 months

    Area under the concentration-time curve (AUC) is a pharmacokinetic parameter that quantitatively describes the total exposure of a drug in the body over a specific period of time

  10. Pharmacokinetics (PK): apparent clearance (CL) of Total Antibody in all phases

    Time frame: up to 36 months

    Apparent clearance (CL) is a pharmacokinetic parameter that describes the rate at which a drug is removed from the body relative to the drug's concentration in the bloodstream or a specific body fluid

  11. Pharmacokinetics (PK): terminal elimination half-life (T1/2) of Total Antibody in all phases

    Time frame: up to 36 months

    Terminal elimination half-life (T1/2) is a pharmacokinetic parameter that characterizes the time it takes for the concentration of a drug in the body to decrease by half during the terminal phase of drug elimination

  12. Pharmacokinetics (PK): time to maximum concentration (Tmax) of Unconjugated payloads in all phases

    Time frame: up to 36 months

    Time to maximum concentration (Tmax) is a pharmacokinetic parameter that refers to the time it takes for a drug or substance to reach its highest concentration in the bloodstream or a specific body compartment after administration

  13. Pharmacokinetics (PK): maximum concentration (Cmax) of Unconjugated payloads in all phases

    Time frame: up to 36 months

    Maximum concentration (Cmax) is a key pharmacokinetic parameter. It represents the highest concentration of a drug or substance that is achieved in the bloodstream or a specific biological fluid or tissue after administration

  14. Pharmacokinetics (PK): area under the concentration-time curve (AUC) of Unconjugated payloads in all phases

    Time frame: up to 36 months

    The area under the concentration - time curve (AUC) is a pharmacokinetic parameter that quantitatively describes the total exposure of a drug in the body over a specific period of time

  15. Pharmacokinetics (PK): apparent clearance (CL) of Unconjugated payloads in all phases

    Time frame: up to 36 months

    Apparent clearance (CL) is a pharmacokinetic parameter that describes the rate at which a drug is removed from the body relative to the drug's concentration in the bloodstream or a specific body fluid

  16. Pharmacokinetics (PK): terminal elimination half-life (T1/2) of unconjugated payloads in all phases

    Time frame: up to 36 months

    Terminal elimination half - life (T1/2) is a pharmacokinetic parameter that characterizes the time it takes for the concentration of a drug in the body to decrease by half during the terminal phase of drug elimination

  17. Assess immunogenicity of ZL-1310 in all phases

    Time frame: up to 36 months

    Incidence of anti-drug antibodies (ADAs) to ZL-1310 in all phases

  18. Evaluate stability and control of disease in all phases

    Time frame: up to 36 months

    BICR- and investigator-determined disease control rate (DCR) in all phases

  19. Evaluate progression-free survival (PFS) in all phases

    Time frame: up to 36 months

    BICR- and investigator-determined PFS in all phases

  20. Evaluate survival in all phases

    Time frame: up to 36 months

    Overall survival (OS) in all phases

Study contacts

Contact information is provided by the study sponsor or research team.

ZaiLab_1310-002_StudyTeam

CONTACT

[email protected]

6503601601

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Collaborators

  • Zai Lab (US) LLC

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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