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

NCT06179069
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
339
clinicaltrials.gov
Lead sponsor
Zai Lab (Shanghai) Co., Ltd.
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Start date
2024-01-23
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Number of sites
38
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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
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Short title
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-31
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First posted
2023-12-21
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Registry last updated
2026-08-21
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Primary completion date
2027-05-30
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Start date
2024-01-23
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Participants
339
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Participant count basis
Estimated
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Planned participants
339
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Protocol amendments
7
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Number of sites
38
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Registry sponsor category
Industry
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Lead sponsor
Zai Lab (Shanghai) Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06179069
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ClinicalTrials.gov ID
NCT06179069
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. 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)

    Timeframe: up to 24 months

    Number of subjects with Dose Limiting Toxicities (DLTs)

  2. 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)

    Timeframe: up to 24 months

    Number of subjects with treatment-emergent adverse events (TEAEs)

  3. 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)

    Timeframe: up to 24 months

    Number of subjects with serious adverse events

  4. Incidence of Treatment Emergent Adverse Events of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3) and in combination with atezolizumab and carboplatin (Part 4)

    Timeframe: up to 24 months

    Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation

  5. Incidence of Serious Adverse-Events (SAEs) of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)

    Timeframe: up to 24 months

    Number of subjects with serious adverse events

  6. Antitumor activity per RECIST v1.1 by investigator's assessment of ZL-1310 as a single agent (Part 2), in combination with atezolizumab (Part 3), and in combination with atezolizumab and carboplatin (Part 4)

    Timeframe: up to 24 months

    antitumor activity per RECIST v1.1 by investigator's assessment

  7. Objective response rate (ORR) per RECIST v1.1 of ZL-1310 as a single agent (Part 2) and in combination with atezolizumab and carboplatin (Part 4)

    Timeframe: up to 24 months

    objective response rate per RECIST v1.1

  8. Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab

    Timeframe: up to 24 months

    disease control rate per RECIST v1.1

  1. Objective response rate (ORR) per RECIST 1.1 of ZL-1310 as a single agent (Part 1A) in combination with atezolizumab (Part 1B), in combination with atezolizumab and carboplatin (Part 1C, Part 3)

    Timeframe: up to 24 months

    Objective Response Rate (ORR) per RECIST 1.1

  2. Disease control rate (DCR) per RECIST v1.1 of ZL-1310 as a single agent (Part 1A and Part 2), in combination with atezolizumab (Part 1B), and in combination with atezolizumab and carboplatin (Part 4)

    Timeframe: up to 24 months

    Disease control rate (DCR) per RECIST v1.1

  3. Duration of response per RECIST v1.1

    Timeframe: up to 24 months

    Duration of response per RECIST v1.1

  4. Progression free survival per RECIST v1.1

    Timeframe: up to 24 months

    Progression free survival per RECIST v1.1

  5. Overall Survival of ZL-1310

    Timeframe: up to 24 months

    Overall Survival of ZL-1310

  6. Pharmacokinetics: Total Antibody of ZL-1310

    Timeframe: up to 24 months

    Pharmacokinetics: Total Antibody of ZL-1310

  7. Pharmacokinetics: Unconjugated payloads of ZL-1310

    Timeframe: up to 24 months

    Pharmacokinetics: Unconjugated payloads of ZL-1310

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • City of HopeDuarte, United StatesWithdrawn
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • Sarah Cannon Research InstituteSarasota, United StatesRecruiting
  • Barbara Ann Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Roswell Park Comprehensive Cancer CenterBuffalo, United StatesRecruiting
  • Duke UniversityDurham, United StatesRecruiting
  • University Hospitals Cleveland Medical CenterCleveland, United StatesRecruiting
  • University of Pittsburgh Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • Medical University of South CarolinaCharleston, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaRecruiting
  • Beijing Cancer HospitalBeijing, ChinaRecruiting
  • The First Affiliated Hospital of Xiamen UniversityXiamen, ChinaWithdrawn
  • Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
  • Harbin Medical University Cancer HospitalHarbin, ChinaWithdrawn
  • Henan Cancer HospitalZhengzhou, ChinaRecruiting
  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhan, ChinaRecruiting
  • Hunan Cancer HospitalChangsha, ChinaWithdrawn
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTerminated
  • The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTerminated
  • Jilin Cancer HospitalCh’ang-ch’un, ChinaActive, not recruiting
  • Liaoning Cancer Hospital & InstituteShenyang, ChinaWithdrawn
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaWithdrawn
  • Affiliated Cancer Hospital of Shandong First Medical UniversityJinan, ChinaRecruiting

And 13 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)