A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
NCT ID: NCT06179069
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
112 participants
INTERVENTIONAL
2024-01-23
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: Part 1A
ZL-1310 as a single-agent
ZL-1310
Drug: ZL-1310
Dose Expansion: Part 1B
ZL-1310 in combination with Atezolizumab
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Dose Escalation: Part 1C
ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Carboplatin
Drug Carboplatin
Dose Expansion: Arm 1 (Part 2)
Dose level 1 of ZL-1310 established from single-agent dose-escalation
ZL-1310
Drug: ZL-1310
Dose Expansion: Arm 2 (Part 2)
Dose level 2 of ZL-1310 established from single-agent dose escalation
ZL-1310
Drug: ZL-1310
Dose Extension: Arm 1 (Part 2)
ZL-1310 as a single agent
ZL-1310
Drug: ZL-1310
Doublet Dose Optimization: Arm 1 (Part 3)
Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Doublet Dose Optimization: Arm 2 (Part 3)
Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Triplet Dose Optimization: Arm 1 (Part 4)
Dose level 1 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + Atezolizumab as maintenance
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Carboplatin
Drug Carboplatin
Triplet Dose Optimization: Arm 2 (Part 4)
Dose level 2 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab + Carboplatin induction followed by ZL-1310 + atezolizumab as induction
ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Carboplatin
Drug Carboplatin
Interventions
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ZL-1310
Drug: ZL-1310
Atezolizumab
Drug Atezolizumab
Carboplatin
Drug Carboplatin
Eligibility Criteria
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Inclusion Criteria
* 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, 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 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
* 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.
18 Years
ALL
No
Sponsors
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Zai Lab (US) LLC
INDUSTRY
Zai Lab (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zai Lab Site 2005
Duarte, California, United States
Zai Lab Site 2030
New Haven, Connecticut, United States
Zai Lab Site 2026
Sarasota, Florida, United States
Zai Lab Site 2013
Detroit, Michigan, United States
Zai Lab Site 2001
Hackensack, New Jersey, United States
Zai Lab Site 2002
Buffalo, New York, United States
Zai Lab Site 2018
Durham, North Carolina, United States
Zai Lab Site 2024
Cleveland, Ohio, United States
Zai Lab Site 2029
Pittsburgh, Pennsylvania, United States
Zai Lab Site 2012
Charleston, South Carolina, United States
Zai Lab Site 2006
Fairfax, Virginia, United States
Zai Lab Site 1004
Hefei, Anhui, China
Zai Lab Site 1005
Beijing, Beijing Municipality, China
Zai Lab Site 1012
Xiamen, Fujian, China
Zai Lab Site 1001
Guangzhou, Guangdong, China
Zai Lab Site 1009
Harbin, Heilongjiang, China
Zai Lab Site 1006
Zhengzhou, Henan, China
Zai Lab 1002
Wuhan, Hubei, China
Zai Lab Site 1014
Changsha, Hunan, China
Zai Lab Site 1016
Nanjing, Jiangsu, China
Zai Lab Site 1003
Nanchang, Jiangxi, China
Zai Lab Site 1008
Ch’ang-ch’un, Jilin, China
Zai Lab Site 1017
Shenyang, Liaoning, China
Zai Lab Site 1015
Xi'an, Shaanxi, China
Zai Lab Site 1011
Jinan, Shandong, China
Zai Lab Site 1010
Shanghai, Shanghai Municipality, China
Zai Lab Site 1013
Chengdu, Sichaun, China
Zai Lab Site 8002
Barcelona, Barcelona, Spain
Zai Lab Site 8003
Madrid, Madrid, Spain
Zai Lab Site 8006
Madrid, Madrid, Spain
Zai Lab Site 8005
Seville, Sevilla, Spain
Zai Lab Site 8004
Valencia, Valencia, Spain
Zai Lab Site 8001
Valencia, Valencia, Spain
Zai Lab Site 8007
Barcelona, , Spain
Zai Lab Site 8009
Madrid, , Spain
Zai Lab Site 8008
Málaga, , Spain
Zai Lab Site 8010
Pozuelo de Alarcón, , Spain
Zai Lab Site 8011
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Site 2005
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Site 2030
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Site 2026
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Site 2013
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Site 2001
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Site 2002
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Site 2018
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Site 2024
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Site 2029
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Site 2012
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Site 2006
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Site 1004
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Site 1005
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Site 1012
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Site 1001
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Site 1009
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Site 1006
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Site 1002
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Site 1014
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Site 1016
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Site 1003
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Site 1008
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Site 1017
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Site 1015
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Site 1011
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Site 1010
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Site 1013
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Site: 8010
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Site: 8011
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Other Identifiers
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ZL-1310-001
Identifier Type: -
Identifier Source: org_study_id
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