Ireland
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Recruiting Phase 1

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

NCT06179069 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2024-01-23
Last updated
2026-08-21

Condition(s) studied

SCLC

Investigational drug(s) / intervention(s)

ZL-1310 →Atezolizumab →Carboplatin →

ZL-1310: Drug: ZL-1310

Atezolizumab: Drug Atezolizumab

Carboplatin: Drug Carboplatin

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
    Number of subjects with Dose Limiting Toxicities (DLTs)
  • 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
    Number of subjects with treatment-emergent adverse events (TEAEs)
  • 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
    Number of subjects with serious adverse events
  • 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) — up to 24 months
    Number of subjects with treatment emergent adverse events leading to dose modifications and/or study treatment discontinuation
  • 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) — up to 24 months
    Number of subjects with serious adverse events
  • 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) — up to 24 months
    antitumor activity per RECIST v1.1 by investigator's assessment
  • 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) — up to 24 months
    objective response rate per RECIST v1.1
  • Disease control rate (DCR) per RECIST v1.1 of ZL-1310 in combination with atezolizumab — up to 24 months
    disease control rate per RECIST v1.1

Trial sites (38)

FacilityCityRegionStatus
City of Hope Duarte California Withdrawn
Yale Cancer Center New Haven Connecticut Recruiting
Sarah Cannon Research Institute Sarasota Florida Recruiting
Barbara Ann Karmanos Cancer Institute Detroit Michigan Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Duke University Durham North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
University of Pittsburgh Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
NEXT Virginia Fairfax Virginia Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Withdrawn
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Withdrawn
Henan Cancer Hospital Zhengzhou Henan Recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Withdrawn
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu Terminated
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi Terminated
Jilin Cancer Hospital Ch’ang-ch’un Jilin Active Not Recruiting
Liaoning Cancer Hospital & Institute Shenyang Liaoning Withdrawn
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi Withdrawn
Affiliated Cancer Hospital of Shandong First Medical University Jinan Shandong Recruiting
Zhongshan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
Sichuan Cancer Hospital Chengdu Sichaun Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON Barcelona Barcelona Recruiting
Hospital Universitario Ramon y Cajal Madrid Madrid Recruiting
Hospital Universitario 12 de Octubre Madrid Madrid Recruiting
Hospital Universitario Virgen Macarena Seville Sevilla Recruiting
Hospital Clinico Universitario de Valencia Valencia Valencia Recruiting
Hospital Universitari i Politecnic La Fe de Valencia Valencia Valencia Recruiting
START Barcelona_HM Nou Delfos Barcelona Spain Recruiting
START MADRID_Hospital Universitario HM Sanchinarro Madrid Spain Recruiting
Hospital Regional Universitario de Malaga - Hospital General H Málaga Spain Recruiting
NEXT Oncology - Hospital Quironsalud Madrid Pozuelo de Alarcón Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06179069 on ClinicalTrials.gov ↗ ← All trials in Spain