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

August 20, 2026 updated by: Zai Lab (Shanghai) Co., Ltd.

A Phase 1b/2, Open-label, Multi-center 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 102200
        • Recruiting
        • Beijing GoBroad Hospital
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510030
        • Recruiting
        • Sun Yat-Sen University Cancer Center
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco/Helen Diller Family Comprehensive Cancer Center
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF St. Francis Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI OP (Oncology Partners)
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology / Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M. D. Anderson Cancer Center
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - Central South
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm
ZL-1310 as a single agent
Drug: ZL-1310
drug ZL-1310

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment Emergent Adverse-Events in Phase 1b
Time Frame: up to 36 months
Number of subjects with treatment-emergent adverse events (TEAEs)
up to 36 months
Incidence of Serious Adverse Events in Phase 1b
Time Frame: up to 36 months
Number of subjects with serious adverse events (SAEs)
up to 36 months
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
up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate preliminary antitumor activity of ZL-1310 as a single agent in Phase 1b
Time Frame: up to 36 months
  1. BICR-determined confirmed ORR in all cohorts
  2. Investigator-determined confirmed ORR in all cohorts
  3. BICR-determined 6-months progression-free survival (PFS6) rate in Cohort 3
  4. Investigator-determined PFS6-rate in Cohort 3
up to 36 months
Evaluate durability of response in Phase 1b
Time Frame: up to 36 months
1. BICR- and investigator-determined duration of response (DOR) in Phase 1b
up to 36 months
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
up to 36 months
Evaluate durability of response in Phase 2
Time Frame: up to 36 months
1. BICR- and investigator-determined duration of DOR in Phase 2
up to 36 months
Incidence of Treatment Emergent Adverse-Events in Phase 2
Time Frame: up to 36 months
Number of subjects with treatment-emergent adverse events (TEAEs)
up to 36 months
Incidence of Serious Adverse Events in Phase 2
Time Frame: up to 36 months
Number of subjects with serious adverse events (SAEs)
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
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
up to 36 months
Evaluate progression-free survival (PFS) in all phases
Time Frame: up to 36 months
BICR- and investigator-determined PFS in all phases
up to 36 months
Evaluate survival in all phases
Time Frame: up to 36 months
Overall survival (OS) in all phases
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zai Lab (Shanghai) Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zai Lab (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZL-1310-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings