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

NCT06885281 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ZL-1310-002
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 20

Brief Summary

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (3)

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

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

  up to 31 months

• Incidence of Serious Adverse Events in Phase 1b

  Number of subjects with serious adverse events (SAEs)

  up to 31 months

• 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

  up to 31 months

Secondary Outcomes (19)

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

  up to 31 months

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

  up to 31 months

• Incidence of Treatment Emergent Adverse-Events in Phase 2

  up to 31 months

• Incidence of Serious Adverse Events in Phase 2

  up to 31 months

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

  up to 31 months

Study Arms (1)

Single Arm

EXPERIMENTAL

ZL-1310 as a single agent

Drug: ZL-1310

Interventions

ZL-1310 DRUG

drug ZL-1310

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead
• Zai Lab (US) LLC: collaborator

Study Sites (20)

Zai Lab Site 2001

San Francisco, California, 94143, United States

RECRUITING

Zai Lab Site 2013

Detroit, Michigan, 48201, United States

RECRUITING

Zai Lab Site 2002

New York, New York, 10065, United States

RECRUITING

Zai Lab Site 2024

Cleveland, Ohio, 44106, United States

RECRUITING

Zai Lab Site 2004

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Zai Lab Site 2014

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Zai Lab Site 2003

Dallas, Texas, 75246, United States

RECRUITING

Zai Lab Site 2007

Houston, Texas, 77030, United States

RECRUITING

Zai Lab Site 2011

McAllen, Texas, 78503, United States

NOT YET RECRUITING

Zai Lab Site 2006

Fairfax, Virginia, 22031, United States

RECRUITING

Zai Lab Site 2012

Norfolk, Virginia, 23502, United States

NOT YET RECRUITING

Zai Lab Site 1002

Beijing, Beijing Municipality, 100142, China

RECRUITING

Zai Lab Site 1013

Beijing, Beijing Municipality, 102200, China

RECRUITING

Zai Lab Site 1009

Xiamen, Fujian, 361003, China

RECRUITING

Zai Lab Site 1016

Guangzhou, Guangdong, 510030, China

RECRUITING

Zai Lab Site 1004

Guangzhou, Guangdong, 510080, China

RECRUITING

Zai Lab Site 1012

Harbin, Heilongjiang, 150081, China

RECRUITING

Zai Lab Site 1006

Changsha, Hunan, 410013, China

RECRUITING

Zai Lab Site 1008

Changchun, Jilin, 130012, China

RECRUITING

Zai Lab Site 1001

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Central Study Contacts

ZaiLab_1310-002_StudyTeam

CONTACT

86 021-61632588; Zailab_1310-002_StudyTeam@zailaboratory.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 20, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CN (9)