Recruiting
Phase 1
Phase 2

ZL-1310

Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Code:

NCT06885281

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZL-1310

Study Details

Brief summary:

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

Conditions

Solid Tumors

Study ID

NCT06885281

Start date

May 12, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

166 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

ZL-1310 as a single agent

Interventions

ZL-1310

drug ZL-1310

Primary outcome measure

  • Incidence of Treatment Emergent Adverse-Events in Phase 1b [ Time Frame: up to 36 months ]
  • Incidence of Serious Adverse Events in Phase 1b [ Time Frame: up to 36 months ]
  • Evaluate antitumor activity of ZL-1310 as a single agent in Phase 2 [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

ZaiLab_1310-002_StudyTeam

6503601601Zailab_1310-002_StudyTeam@zailaboratory.com

Locations

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

Recruiting

San Francisco, California, United States, 94143

OSF St. Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Karmanos Cancer Center

Recruiting

Detroit, Michigan, United States, 48201

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

SCRI OP (Oncology Partners)

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology / Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Central South

Recruiting

McAllen, Texas, United States, 78503

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Last update posted

Aug 21, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zai Lab (Shanghai) Co., Ltd. on 2026-08-21.