A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Efficacy, and Pharmacokinetics in Participants With Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ZL-1310 alone or with atezolizumab, with or without carboplatin, in adults with small cell lung cancer that has spread. It looks at safety, how well treatment works, and how the body handles ZL-1310.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and sign a form agreeing to join the study.
- Have small cell lung cancer that has spread widely and did not change from another type of cancer.
- Meet the past treatment rules for your study part. Some parts require no past treatment; others require cancer that grew during or after certain treatments.
- For maintenance treatment, have had at least 4 rounds of the required first treatment, with cancer that has shrunk, disappeared, or stayed stable.
- Be fully active or able to do light work, even if hard physical activity is limited.
- Have at least one tumor that can be measured on a CT, PET/CT, or MRI scan.
- Agree to have a tumor sample taken, or provide a stored tumor sample.
- Be expected to live at least 3 months.
Who can't join
- Have another cancer that is growing or needed active treatment in the past 2 years. Some skin cancers, early cervical cancer, and other cancers are allowed.
- Have brain tumors from cancer spread that cause symptoms or need treatment, or cancer in the lining around the brain or spinal cord. Some brain tumors are allowed in Parts 2, 3, and 4 under special rules.
- Have had cancer drugs or an experimental treatment or device within 3 weeks, radiation not meant only to ease symptoms within 2 weeks, or major surgery within 4 weeks before study treatment.
- Have an allergy to a study treatment ingredient, organs that do not work well enough, or serious heart problems within the past 3 months.
- Have serious lung illness, lung swelling from radiation, or certain immune system, connective tissue, or swelling-related diseases.
- Have a weak immune system or recently used medicines that weaken it; have had a live vaccine within 30 days; or recently used certain medicines that affect how the body breaks down drugs.
- Be pregnant or breastfeeding.
- For Parts 1C and 4, have had certain immune-based cancer treatments. For Parts 1B and 1C, have recently used certain medicines that boost the immune system.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (11)
CA
- City of Hope · Duarte, CA 91010More trials in Duarte
CT
- Yale Cancer Center · New Haven, CT 06519More trials in New Haven
FL
- Sarah Cannon Research Institute · Sarasota, FL 34232More trials in Sarasota
MI
- Barbara Ann Karmanos Cancer Institute · Detroit, MI 48201More trials in Detroit
NC
- Duke University · Durham, NC 27710More trials in Durham
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601More trials in Hackensack
NY
- Roswell Park Comprehensive Cancer Center · Buffalo, NY 14263More trials in Buffalo
OH
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
PA
- University of Pittsburgh Hillman Cancer Center · Pittsburgh, PA 15232More trials in Pittsburgh
SC
- Medical University of South Carolina · Charleston, SC 29425More trials in Charleston
VA
- NEXT Virginia · Fairfax, VA 22031More trials in Fairfax