Skip to main content
Back to Trials
NCT06179069PHASE1Recruiting

A Study of ZL-1310 in Subjects With Small Cell Lung Cancer

Zai Lab (Shanghai) Co., Ltd.

Start Date

1/23/2024

Completion Date

7/31/2027

Summary

An open-label, multicenter study of ZL-1310 as a single agent and in combination with Atezolizumab (with and without Carboplatin) to evaluate the safety, efficacy, and pharmacokinetics in subjects with small cell lung cancer

Detailed Description

This is an open-label, ascending, multiple-dose, phase 1 study evaluating ZL-1310 as a single agent, in combination with Atezolizumab, and in combination with Atezolizumab and Carboplatin in subjects with extensive SCLC.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Signed informed consent * Participant with metastatic or extensive-stage small cell lung cancer (de novo, not transformed) and for Part 1A and 1B must have documented disease progression during or following a platinum-based chemotherapy regimen. For Part 1C and Part 4, no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC). For Part 1B backfill and Part 3, first-line setting: no prior systemic treatment for SCLC (including chemoradiotherapy for limited-stage SCLC); or, first-line maintenance setting: participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin, etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. For Part 2-1, participants must have received no more than 2 lines of prior therapies in the extensive-stage setting, and progressed on or after a platinum-based chemotherapy regimen AND an anti-DLL3 T-cell engager (TCE). For Part 3, participants have received at least 4 cycles of 1L induction therapy with carboplatin or cisplatin etoposide, and anti-PD-L1 inhibitor for ES-SCLC with ongoing CR, PR, or SD per RECIST v1.1 assessed by the investigator. * Adult men and women ≥18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI. * Subjects must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at screening per protocol guidelines. * Life Expectancy \>/= 3 months. Exclusion Criteria: * Participants with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy. * Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, Part 3, and Part 4 the following subjects can be enrolled if they have a stable neurologic status for at least 2 weeks prior to the first dose of ZL-1310: 1. Subjects with untreated and asymptomatic brain metastases. 2. Subjects with treated brain metastases that are no longer symptomatic (i.e. without neurologic signs or symptoms), who require no treatment with steriods or anticonvulsants and have recovered from the actue toxic effects of radiotherapy. * Subjects with leptomeningeal disease. * Treatment with any systemic anti-cancer treatment or other investigational products/ device within 3 weeks before first dose of study treatment. * Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or have had 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. * Inadequate organ function (as defined in protocol) within 10 days prior to the first dose of study treatment, * Participants with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer. * Participants have received a live or live-attenuated vaccine within 30 days of planned start of study therapy. * 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. * 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 study treatment, whichever is longer. * For Part 1C and Part 4 (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies. * For Part 1B (ZL-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 in combination with Atezolizumab and Carboplatin), participants who received systemic immunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to the initiation of study treatment.

Interventions

DRUG

ZL-1310

DRUG

Atezolizumab

DRUG

Carboplatin

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

SCLC

Locations

City of Hope

Duarte, California 91010

United States

Yale Cancer Center

New Haven, Connecticut 06519

United States

Sarah Cannon Research Institute

Sarasota, Florida 34232

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Duke University

Durham, North Carolina 27710

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

University of Pittsburgh Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui 230022

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361000

China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong 510030

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Henan Cancer Hospital

Zhengzhou, Henan 450008

China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei 430022

China

Hunan Cancer Hospital

Changsha, Hunan 410013

China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu 210008

China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006

China

Jilin Cancer Hospital

Ch’ang-ch’un, Jilin 130012

China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning 110041

China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi 710061

China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong 250000

China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality 200032

China

Sichuan Cancer Hospital

Chengdu, Sichaun 610041

China

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, Barcelona 8035

Spain

Hospital Universitario Ramon y Cajal

Madrid, Madrid 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid 28041

Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla 41009

Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia 46010

Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Valencia 46026

Spain

START Barcelona_HM Nou Delfos

Barcelona, 08023

Spain

START MADRID_Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Hospital Regional Universitario de Malaga - Hospital General H

Málaga, 29010

Spain

NEXT Oncology - Hospital Quironsalud Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain