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

NCT06179069 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ZL-1310-001
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 38

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

Outcome Measures

Primary Outcomes (8)

• 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)

  Number of subjects with Dose Limiting Toxicities (DLTs)

  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)

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

  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)

  Number of subjects with serious adverse events

  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)

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

  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)

  Number of subjects with serious adverse events

  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)

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

  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)

  objective response rate per RECIST v1.1

  up to 24 months

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

  disease control rate per RECIST v1.1

  up to 24 months

Secondary Outcomes (7)

• 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)

  up to 24 months

• 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)

  up to 24 months

• Duration of response per RECIST v1.1

  up to 24 months

• Progression free survival per RECIST v1.1

  up to 24 months

• Overall Survival of ZL-1310

  up to 24 months

Study Arms (10)

Dose Escalation: Part 1A

EXPERIMENTAL

ZL-1310 as a single-agent

Drug: ZL-1310

Dose Expansion: Part 1B

EXPERIMENTAL

ZL-1310 in combination with Atezolizumab

Drug: ZL-1310; Drug: Atezolizumab

Dose Escalation: Part 1C

EXPERIMENTAL

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

Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin

Dose Expansion: Arm 1 (Part 2)

EXPERIMENTAL

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

Drug: ZL-1310

Dose Expansion: Arm 2 (Part 2)

EXPERIMENTAL

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

Drug: ZL-1310

Dose Extension: Arm 1 (Part 2)

EXPERIMENTAL

ZL-1310 as a single agent

Drug: ZL-1310

Doublet Dose Optimization: Arm 1 (Part 3)

EXPERIMENTAL

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

Drug: ZL-1310; Drug: Atezolizumab

Doublet Dose Optimization: Arm 2 (Part 3)

EXPERIMENTAL

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

Drug: ZL-1310; Drug: Atezolizumab

Triplet Dose Optimization: Arm 1 (Part 4)

EXPERIMENTAL

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

Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin

Triplet Dose Optimization: Arm 2 (Part 4)

EXPERIMENTAL

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

Drug: ZL-1310; Drug: Atezolizumab; Drug: Carboplatin

Interventions

ZL-1310 DRUG

Drug: ZL-1310

Dose Escalation: Part 1A; Dose Escalation: Part 1C; Dose Expansion: Arm 1 (Part 2); Dose Expansion: Arm 2 (Part 2); Dose Expansion: Part 1B; Dose Extension: Arm 1 (Part 2); Doublet Dose Optimization: Arm 1 (Part 3); Doublet Dose Optimization: Arm 2 (Part 3); Triplet Dose Optimization: Arm 1 (Part 4); Triplet Dose Optimization: Arm 2 (Part 4)

Atezolizumab DRUG

Drug Atezolizumab

Dose Escalation: Part 1C; Dose Expansion: Part 1B; Doublet Dose Optimization: Arm 1 (Part 3); Doublet Dose Optimization: Arm 2 (Part 3); Triplet Dose Optimization: Arm 1 (Part 4); Triplet Dose Optimization: Arm 2 (Part 4)

Carboplatin DRUG

Drug Carboplatin

Dose Escalation: Part 1C; Triplet Dose Optimization: Arm 1 (Part 4); Triplet Dose Optimization: Arm 2 (Part 4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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.

You may not qualify if:

• 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:
• Subjects with untreated and asymptomatic brain metastases.
• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead
• Zai Lab (US) LLC: collaborator

Study Sites (38)

Zai Lab Site 2005

Duarte, California, 91010, United States

RECRUITING

Zai Lab Site 2030

New Haven, Connecticut, 06519, United States

RECRUITING

Zai Lab Site 2026

Sarasota, Florida, 34232, United States

RECRUITING

Zai Lab Site 2013

Detroit, Michigan, 48201, United States

RECRUITING

Zai Lab Site 2001

Hackensack, New Jersey, 07601, United States

RECRUITING

Zai Lab Site 2002

Buffalo, New York, 14263, United States

RECRUITING

Zai Lab Site 2018

Durham, North Carolina, 27710, United States

RECRUITING

Zai Lab Site 2024

Cleveland, Ohio, 44106, United States

RECRUITING

Zai Lab Site 2029

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

Zai Lab Site 2012

Charleston, South Carolina, 29425, United States

RECRUITING

Zai Lab Site 2006

Fairfax, Virginia, 22031, United States

RECRUITING

Zai Lab Site 1004

Hefei, Anhui, 230022, China

RECRUITING

Zai Lab Site 1005

Beijing, Beijing Municipality, 100142, China

RECRUITING

Zai Lab Site 1012

Xiamen, Fujian, 361000, China

NOT YET RECRUITING

Zai Lab Site 1001

Guangzhou, Guangdong, 510030, China

RECRUITING

Zai Lab Site 1009

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

Zai Lab Site 1006

Zhengzhou, Henan, 450008, China

RECRUITING

Zai Lab 1002

Wuhan, Hubei, 430022, China

RECRUITING

Zai Lab Site 1014

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Zai Lab Site 1016

Nanjing, Jiangsu, 210008, China

RECRUITING

Zai Lab Site 1003

Nanchang, Jiangxi, 330006, China

RECRUITING

Zai Lab Site 1008

Ch’ang-ch’un, Jilin, 130012, China

RECRUITING

Zai Lab Site 1017

Shenyang, Liaoning, 110041, China

NOT YET RECRUITING

Zai Lab Site 1015

Xi'an, Shaanxi, 710061, China

NOT YET RECRUITING

Zai Lab Site 1011

Jinan, Shandong, 250000, China

RECRUITING

Zai Lab Site 1010

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zai Lab Site 1013

Chengdu, Sichaun, 610041, China

RECRUITING

Zai Lab Site 8002

Barcelona, Barcelona, 8035, Spain

RECRUITING

Zai Lab Site 8003

Madrid, Madrid, 28034, Spain

RECRUITING

Zai Lab Site 8006

Madrid, Madrid, 28041, Spain

RECRUITING

Zai Lab Site 8005

Seville, Sevilla, 41009, Spain

RECRUITING

Zai Lab Site 8004

Valencia, Valencia, 46010, Spain

RECRUITING

Zai Lab Site 8001

Valencia, Valencia, 46026, Spain

RECRUITING

Zai Lab Site 8007

Barcelona, 08023, Spain

NOT YET RECRUITING

Zai Lab Site 8009

Madrid, 28050, Spain

NOT YET RECRUITING

Zai Lab Site 8008

Málaga, 29010, Spain

NOT YET RECRUITING

Zai Lab Site 8010

Pozuelo de Alarcón, 28223, Spain

NOT YET RECRUITING

Zai Lab Site 8011

Seville, 41013, Spain

NOT YET RECRUITING

MeSH Terms

Interventions

atezolizumab; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Yun Wang

CONTACT

8579713465; Study-ZL-1310-001@zailaboratory.com

Mona Qureshi

CONTACT

Study-ZL-1310-001@zailaboratory.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 21, 2023
• Study Start: January 23, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11); US (11); CN (16)