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

NCT ID: NCT06885281

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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This is an open-label, multiple-center, phase 1b/2 study of ZL-1310 in selected solid tumors.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

ZL-1310 as a single agent

Group Type EXPERIMENTAL

ZL-1310

Intervention Type DRUG

drug ZL-1310

Interventions

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ZL-1310

drug ZL-1310

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zai Lab (US) LLC

INDUSTRY

Sponsor Role collaborator

Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zai Lab Site 2001

San Francisco, California, United States

Site Status RECRUITING

Zai Lab Site 2002

New York, New York, United States

Site Status RECRUITING

Zai Lab Site 2024

Cleveland, Ohio, United States

Site Status RECRUITING

Zai Lab Site 2004

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Zai Lab Site 2003

Dallas, Texas, United States

Site Status RECRUITING

Zai Lab Site 2007

Houston, Texas, United States

Site Status RECRUITING

Zai Lab Site 2006

Fairfax, Virginia, United States

Site Status RECRUITING

Zai Lab Site 1002

Beijing, Beijing Municipality, China

Site Status RECRUITING

Zai Lab Site 1013

Beijing, Beijing Municipality, China

Site Status RECRUITING

Zai Lab Site 1009

Xiamen, Fujian, China

Site Status RECRUITING

Zai Lab Site 1016

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Zai Lab Site 1004

Guangzhou, Guangdong, China

Site Status RECRUITING

Zai Lab Site 1012

Harbin, Heilongjiang, China

Site Status RECRUITING

Zai Lab Site 1006

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Zai Lab Site 1008

Changchun, Jilin, China

Site Status NOT_YET_RECRUITING

Zai Lab Site 1001

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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United States China

Central Contacts

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ZaiLab_1310-002_StudyTeam

Role: CONTACT

86 021-61632588

Facility Contacts

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Site 2001

Role: primary

Site 2002

Role: primary

Site 2024

Role: primary

Site 2004

Role: primary

Site 2003

Role: primary

Site 2007

Role: primary

Site 2006

Role: primary

Site 1002

Role: primary

Site 1013

Role: primary

Site 1009

Role: primary

Site 1016

Role: primary

Site 1004

Role: primary

Site 1012

Role: primary

Site 1006

Role: primary

Site 1008

Role: primary

Site 1001

Role: primary

Other Identifiers

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ZL-1310-002

Identifier Type: -

Identifier Source: org_study_id

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