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Solid TumorsPhase 1/2NCT06885281

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

A Phase 1/2 study testing ZL-1310 in people with Solid Tumors, run by Zai Lab (Shanghai) Co., Ltd. at 23 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
ZL-1310
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
23 sitesin 2 countries
Study dates
12 May 2025to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

ZaiLab_1310-002_StudyTeam contact

6503601601

Zailab_1310-002_StudyTeam@zailaboratory.com

23 sites in 2 countries

United States12 sites, 12 recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Texas Oncology / Sammons Cancer Center

    Dallas, Texas, 75246

    Recruiting

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Texas Oncology - Central South

    McAllen, Texas, 78503

    Recruiting

  • SCRI OP (Oncology Partners)

    Nashville, Tennessee, 37203

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • University of California San Francisco/Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

    Recruiting

Other trials in United States

China11 sites, 11 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Beijing Gobroad Hospital

    Beijing, Beijing Municipality, 102200

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510030

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Recruiting

Other trials in China

About this study

Official title: 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

Read the 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

Conditions
Solid Tumors
Being tested
ZL-1310

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZL-1310Drug

    drug ZL-1310

Study groups in NCT06885281
Study groupRoleWhat they receive
Single ArmExperimentalZL-1310 as a single agent
Receives: Drug: ZL-1310

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: up to 36 months

  2. Incidence of Serious Adverse Events in Phase 1b

    Number of subjects with serious adverse events (SAEs)

    Measured: up to 36 months

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

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

    Measured: up to 36 months

Secondary outcomes (20)

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

    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

    Measured: up to 36 months

  2. Evaluate durability of response in Phase 1b

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

    Measured: up to 36 months

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

    Investigator-determined confirmed ORR in Phase 2

    Measured: up to 36 months

  4. Evaluate durability of response in Phase 2

    1. BICR- and investigator-determined duration of DOR in Phase 2

    Measured: up to 36 months

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

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

    Measured: up to 36 months

  6. Incidence of Serious Adverse Events in Phase 2

    Number of subjects with serious adverse events (SAEs)

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

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

    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

    Measured: up to 36 months

  17. Assess immunogenicity of ZL-1310 in all phases

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

    Measured: up to 36 months

  18. Evaluate stability and control of disease in all phases

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

    Measured: up to 36 months

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

    BICR- and investigator-determined PFS in all phases

    Measured: up to 36 months

  20. Evaluate survival in all phases

    Overall survival (OS) in all phases

    Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start12 May 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885281
Sponsor's protocol ID
ZL-1310-002
Status last verified
Jun 2026
First submitted
24 Feb 2025
Last updated
21 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ZL-1310 in people with Solid Tumors, run by Zai Lab (Shanghai) Co., Ltd. at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ZaiLab_1310-002_StudyTeam (6503601601, Zailab_1310-002_StudyTeam@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse-Events in Phase 1b (time frame: up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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Clinical Trial NCT06885281 | AzTrials