Recruiting
Phase 1

ZL-1310

Sponsor:

Zai Lab (Shanghai) Co., Ltd.

Code:

NCT06179069

Conditions

SCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ZL-1310

Atezolizumab

Carboplatin

Study Details

Brief 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

Conditions

SCLC

Study ID

NCT06179069

Start date

Jan 23, 2024

Status verified date

Mar, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

339 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation: Part 1A

ZL-1310 as a single-agent

experimental: Dose Expansion: Part 1B

ZL-1310 in combination with Atezolizumab

experimental: Dose Escalation: Part 1C

ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance

experimental: Dose Expansion: Arm 1 (Part 2)

Dose level 1 of ZL-1310 established from single-agent dose-escalation

experimental: Dose Expansion: Arm 2 (Part 2)

Dose level 2 of ZL-1310 established from single-agent dose escalation

experimental: Dose Extension: Arm 1 (Part 2)

ZL-1310 as a single agent

experimental: Doublet Dose Optimization: Arm 1 (Part 3A)

Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab

experimental: Doublet Dose Optimization: Arm 2 (Part 3A)

Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab

experimental: Triplet Dose Optimization: Arm 1 (Part 4A)

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

experimental: Triplet Dose Optimization: Arm 2 (Part 4A)

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

experimental: Dose Extension: Part 2-1

single-agent dose extension for Post-anti-DLL3

experimental: Doublet Dose Extension: Part 3B

Doublet dose extension for 1L maintenance only OR 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.

experimental: Triplet Dose Extension: Part 4B

Triplet dose extension for 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.

Interventions

ZL-1310

Drug: ZL-1310

Atezolizumab

Drug Atezolizumab

Carboplatin

Drug Carboplatin

Primary outcome measure

  • 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 24 months ]
  • 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) [ Time Frame: up to 24 months ]
  • 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) [ Time Frame: up to 24 months ]
  • 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) [ Time Frame: up to 24 months ]
  • 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) [ Time Frame: up to 24 months ]
  • Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

Erin Nurre

6503601601Study-ZL-1310-001@zailaboratory.com

Mona Qureshi

6503601601Study-ZL-1310-001@zailaboratory.com

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06519

Sarah Cannon Research Institute

Recruiting

Sarasota, Florida, United States, 34232

Barbara Ann Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Duke University

Recruiting

Durham, North Carolina, United States, 27710

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

University of Pittsburgh Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Zai Lab (Shanghai) Co., Ltd.

Last update posted

Aug 21, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zai Lab (Shanghai) Co., Ltd. on 2026-08-21.