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NCT06885281PHASE1, PHASE2Recruiting

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

Zai Lab (Shanghai) Co., Ltd.

Start Date

5/12/2025

Completion Date

4/1/2028

Summary

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

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

ZL-1310

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Conditions

Solid Tumors

Locations

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

San Francisco, California 94143

United States

OSF St. Francis Medical Center

Peoria, Illinois 61637

United States

Karmanos Cancer Center

Detroit, Michigan 48201

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10065

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

SCRI OP (Oncology Partners)

Nashville, Tennessee 37203

United States

Texas Oncology / Sammons Cancer Center

Dallas, Texas 75246

United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States

Texas Oncology - Central South

McAllen, Texas 78503

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Beijing Gobroad Hospital

Beijing, Beijing Municipality 102200

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510030

China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong 510080

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150081

China

Hunan Cancer Hospital

Changsha, Hunan 410013

China

Jilin Cancer Hospital

Changchun, Jilin 130012

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200000

China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality 200040

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China