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: 166
• Locations: 2 countries
• Sites: 23

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 36 months

• Incidence of Serious Adverse Events in Phase 1b

  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

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

  up to 36 months

Secondary Outcomes (20)

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

  up to 36 months

• Evaluate durability of response in Phase 1b

  up to 36 months

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

  up to 36 months

• Evaluate durability of response in Phase 2

  up to 36 months

• Incidence of Treatment Emergent Adverse-Events in Phase 2

  up to 36 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)
• 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)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

Sponsors & Collaborators

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

Study Sites (23)

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

San Francisco, California, 94143, United States

RECRUITING

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

RECRUITING

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

SCRI OP (Oncology Partners)

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology / Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Central South

McAllen, Texas, 78503, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Gobroad Hospital

Beijing, Beijing Municipality, 102200, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510030, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

ZaiLab_1310-002_StudyTeam

CONTACT

6503601601; 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): April 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); CN (11)