An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

SCLC Clinical Trial

Official title:

An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects With Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179069
• Other study ID #: ZL-1310-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 23, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Zai Lab (Hong Kong), Ltd.
• Contact: Herman Liu
• Phone: 8579713465
• Email: herman.liu[@]zailaboratory.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Description:

This is an open-label, ascending, multiple-dose, phase 1 study of ZL-1310 administered intravenously (IV) every 3 weeks in subjects with relapsed/refractory (r/r) metastatic SCLC who have progressed after at least one platinum-based chemotherapy regimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: December 31, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent
• Subjects must have histologically or cytologically confirmed metastatic or extensive-stage small cell lung cancer with documented disease progression during or following a platinum-based chemotherapy regimen. No more than 3 prior regimens in the metastatic or extensive stage are allowed.
• 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.
• Life Expectancy >3 months.

Exclusion Criteria:

• Subjects 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.
• Subjects with leptomeningeal metastasis.
• 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.
• Out of range lab value (as defined in protocol) within 10 days prior to the first dose of study treatment,
• Subjects 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.
• Subjects 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 not limited to pneumonitis.
• Pregnant or nursing (lactating) women.
• Subjects 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.

Related Conditions & MeSH terms

• SCLC
• Small Cell Lung Carcinoma

Intervention

Drug:
• ZL-1310
Drug: ZL-1310

Locations

Country	Name	City	State
China	Zai Lab Site 1005	Bejing	Bejing
China	Zai Lab Site 1001	Guangzhou	Guangdong
China	Zai Lab Site 1003	Nanchang	Jiangxi
China	Zai Lab 1002	Wuhan	Hubei
United States	Zai Lab Site 2002	Buffalo	New York
United States	Zai Lab Site 2012	Charleston	South Carolina
United States	Zai Lab Site 2024	Cleveland	Ohio
United States	Zai Lab Site 2013	Detroit	Michigan
United States	Zai Lab Site 2005	Duarte	California
United States	Zai Lab Site 2018	Durham	North Carolina
United States	Zai Lab Site 2006	Fairfax	Virginia
United States	Zai Lab Site 2008	Falls Church	Virginia
United States	Zai Lab Site 2001	Hackensack	New Jersey
United States	Zai Lab Site 2026	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Zai Lab (Shanghai) Co., Ltd.	Zai Lab (US) LLC

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicities	Number of subjects with Dose Limiting Toxicities (DLTs); Number of subjects with Dose Limiting Toxicities (DLTs)	up to 24 months
Primary	Incidence of Treatment Emergent Adverse-Events	Number of subjects with treatment-emergent adverse events (TEAEs)	up to 24 months
Primary	Incidence of Serious Adverse Events	Number of subjects with serious adverse events (SAEs)	up to 24 months
Secondary	ORR per RECIST 1.1	Objective Response Rate (ORR) per RECIST 1.1	up to 24 months
Secondary	Duration of Response per RECIST 1.1	Duration of Response per RECIST 1.1	up to 24 months
Secondary	PFS per RECIST 1.1	Progression free survival (PFS) per RECIST 1.1	up to 24 months
Secondary	DCR per RECIST 1.1	Disease Control Rate (DCR) per RECIST 1.1	up to 24 months
Secondary	Overall Survival	Overall Survival (OS)	up to 24 months
Secondary	Pharmacokinetics (PK): Total Antibody	Total Antibody	up to 24 months
Secondary	Pharmacokinetics (PK): Unconjugated payloads	Unconjugated payloads	up to 24 months