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

NCT06179069 · Zai Lab (Hong Kong), Ltd.
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Official title
An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer
About this study
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
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.
Study design
Enrollment target: 339 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-23
Estimated completion: 2027-07-31
Last updated: 2026-04-03
Interventions
Drug: ZL-1310Drug: AtezolizumabDrug: Carboplatin
Primary outcomes
  • Incidence of Dose Limiting Toxicities of ZL-1310 as a single agent (Part 1A), in combination with Atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) (up to 24 months)
  • Incidence of Treatment Emergent Adverse-Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) (up to 24 months)
  • Incidence of Serious Adverse Events of ZL-1310 as a single agent (Part 1A), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 1C) (up to 24 months)
Sponsor
Zai Lab (Shanghai) Co., Ltd. · industry
With: Zai Lab (US) LLC
Contacts & investigators
ContactErin Nurre · contact · Study-ZL-1310-001@zailaboratory.com · 8596094423
ContactMona Qureshi · contact · Study-ZL-1310-001@zailaboratory.com
All locations (38)
Zai Lab Site 2005Recruiting
Duarte, California, United States
Zai Lab Site 2030Recruiting
New Haven, Connecticut, United States
Zai Lab Site 2026Recruiting
Sarasota, Florida, United States
Zai Lab Site 2013Recruiting
Detroit, Michigan, United States
Zai Lab Site 2001Recruiting
Hackensack, New Jersey, United States
Zai Lab Site 2002Recruiting
Buffalo, New York, United States
Zai Lab Site 2018Recruiting
Durham, North Carolina, United States
Zai Lab Site 2024Recruiting
Cleveland, Ohio, United States
Zai Lab Site 2029Not Yet Recruiting
Pittsburgh, Pennsylvania, United States
Zai Lab Site 2012Recruiting
Charleston, South Carolina, United States
Zai Lab Site 2006Recruiting
Fairfax, Virginia, United States
Zai Lab Site 1004Recruiting
Hefei, Anhui, China
Zai Lab Site 1005Recruiting
Beijing, Beijing Municipality, China
Zai Lab Site 1012Not Yet Recruiting
Xiamen, Fujian, China
Zai Lab Site 1001Recruiting
Guangzhou, Guangdong, China
Zai Lab Site 1009Not Yet Recruiting
Harbin, Heilongjiang, China
Zai Lab Site 1006Recruiting
Zhengzhou, Henan, China
Zai Lab 1002Recruiting
Wuhan, Hubei, China
Zai Lab Site 1014Not Yet Recruiting
Changsha, Hunan, China
Zai Lab Site 1016Recruiting
Nanjing, Jiangsu, China
Zai Lab Site 1003Recruiting
Nanchang, Jiangxi, China
Zai Lab Site 1008Recruiting
Ch’ang-ch’un, Jilin, China
Zai Lab Site 1017Not Yet Recruiting
Shenyang, Liaoning, China
Zai Lab Site 1015Not Yet Recruiting
Xi'an, Shaanxi, China
Zai Lab Site 1011Recruiting
Jinan, Shandong, China
Zai Lab Site 1010Recruiting
Shanghai, Shanghai Municipality, China
Zai Lab Site 1013Recruiting
Chengdu, Sichaun, China
Zai Lab Site 8002Recruiting
Barcelona, Barcelona, Spain
Zai Lab Site 8003Recruiting
Madrid, Madrid, Spain
Zai Lab Site 8006Recruiting
Madrid, Madrid, Spain
Zai Lab Site 8005Recruiting
Seville, Sevilla, Spain
Zai Lab Site 8004Recruiting
Valencia, Valencia, Spain
Zai Lab Site 8001Recruiting
Valencia, Valencia, Spain
Zai Lab Site 8007Not Yet Recruiting
Barcelona, Spain
Zai Lab Site 8009Not Yet Recruiting
Madrid, Spain
Zai Lab Site 8008Not Yet Recruiting
Málaga, Spain
Zai Lab Site 8010Not Yet Recruiting
Pozuelo de Alarcón, Spain
Zai Lab Site 8011Not Yet Recruiting
Seville, Spain
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer · TrialPath