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

Last updated: January 9, 2025
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

Carboplatin

ZL-1310

Atezolizumab

Clinical Study ID

NCT06179069
ZL-1310-001
  • Ages > 18
  • All Genders

Study Summary

An Open-label, Multicenter Study of ZL-1310 as a Single Agent and In Combination with Atezolizumab to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • Subjects must have histologically or cytologically confirmed metastatic orextensive-stage small cell lung cancer with documented disease progression during orfollowing a platinum-based chemotherapy regimen. No more than 3 prior regimens inthe metastatic or extensive stage are allowed.

  • 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 v1.1on CT, PET/CT, or MRI.

  • Subjects must be willing to undergo a tumor biopsy or must provide archived tumortissue sample at screening per protocol guidelines.

  • Life Expectancy >3 months.

Exclusion

Exclusion Criteria:

  • Subjects with another known malignancy that is progressing or requires activetreatment within the last 2 years. Exceptions: basal cell carcinoma of the skin orlocalized squamous cell carcinoma of the skin with previously administered curativetreatment, in situ cervical cancer, or other cancers that do not require systemicanti-cancer therapies and will not impact life expectancy.

  • Symptomatic or untreated brain metastasis requiring concurrent treatment. For Part 2, the following subjects can be enrolled if they have a stable neurologic statusfor 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 steriodsor anticonvulsants and have recovered from the actue toxic effects ofradiotherapy.

  • Subjects with leptomeningeal metastasis.

  • 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 orhave 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.

  • Out of range lab value (as defined in protocol) within 10 days prior to the firstdose of study treatment,

  • Subjects with a diagnosis of immunodeficiency or receiving chronic systemic steroidtherapy or any other form of immunosuppressive therapy within 14 days or 5half-lives before the first dose of study treatment, whichever is longer.

  • Subjects have received a live or live-attenuated vaccine within 30 days of plannedstart 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 not limited to pneumonitis.

  • Pregnant or nursing (lactating) women.

  • Subjects who have been on concomitant strong CYP3A or CYP2D6 inhibitors within 14days or 5 half-lives before the first study treatment, whichever is longer.

  • For Part 1C only (ZL-1310 in combination with Atezolizumab and Carboplatin),subjects who received prior treatment with CD137agonists or immune checkpointblockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies.

  • For Part 1B (Z-1310 in combination with Atezolizumab) and Part 1C (ZL-1310 incombination with Atezolizumab and Carboplatin), subjects who received systemicimmunostimulatory agents (including but not limited to, IFNs and IL2) within 4 weeksor 5 drug-elimination half-lives prior to the initiation of study treatment.

Study Design

Total Participants: 112
Treatment Group(s): 3
Primary Treatment: Carboplatin
Phase: 1
Study Start date:
January 23, 2024
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Zai Lab Site 1004

    Hefei, Anhui 230022
    China

    Active - Recruiting

  • Zai Lab Site 1005

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Zai Lab Site 1005

    Bejing, Bejing 100142
    China

    Site Not Available

  • Zai Lab Site 1012

    Xiamen, Fujian 361000
    China

    Site Not Available

  • Zai Lab Site 1001

    Guangzhou, Guangdong 510030
    China

    Active - Recruiting

  • Zai Lab Site 1009

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Zai Lab Site 1006

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Zai Lab 1002

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Zai Lab Site 1014

    Changsha, Hunan 410013
    China

    Site Not Available

  • Zai Lab Site 1016

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Zai Lab Site 1003

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Zai Lab Site 1008

    Ch'ang-ch'un, Jilin 130012
    China

    Active - Recruiting

  • Zai Lab Site 1017

    Shenyang, Liaoning 110041
    China

    Site Not Available

  • Zai Lab Site 1015

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Zai Lab Site 1011

    Jinan, Shandong 250000
    China

    Active - Recruiting

  • Zai Lab Site 1010

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Zai Lab Site 1013

    Chengdu, Sichaun 610041
    China

    Active - Recruiting

  • Zai Lab Site 8002

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Zai Lab Site 8003

    Madrid, 28034
    Spain

    Active - Recruiting

  • Zai Lab Site 8006

    Madrid, 28041
    Spain

    Active - Recruiting

  • Zai Lab Site 8005

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Zai Lab Site 8001

    Valencia, 46026
    Spain

    Active - Recruiting

  • Zai Lab Site 8004

    Valencia, 46010
    Spain

    Active - Recruiting

  • Zai Lab Site 2005

    Duarte, California 91010
    United States

    Active - Recruiting

  • Zai Lab Site 2030

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Zai Lab Site 2026

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Zai Lab Site 2013

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Zai Lab Site 2001

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Zai Lab Site 2002

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Zai Lab Site 2018

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Zai Lab Site 2024

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Zai Lab Site 2029

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Zai Lab Site 2012

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Zai Lab Site 2006

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Zai Lab Site 2008

    Falls Church, Virginia 22042
    United States

    Site Not Available

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