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

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

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

Study Overview

• Status: Recruiting
• Conditions: SCLC
• Intervention / Treatment: Drug: ZL-1310

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Herman Liu; Phone Number: 8579713465; Email: herman.liu@zailaboratory.com
• Study Contact Backup: Name: Clarence Eng; Phone Number: 8579713465; Email: clarence.eng@zailaboratory.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Not yet recruiting
      • Zai Lab Site 2005
      • Contact: Site 2005
  • Florida
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Zai Lab Site 2026
      • Contact: Site 2026
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Not yet recruiting
      • Zai Lab Site 2013
      • Contact: Site 2013
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Zai Lab Site 2001
      • Contact: Site 2001
  • New York
    • Buffalo, New York, United States, 14263
      • Not yet recruiting
      • Zai Lab Site 2002
      • Contact: Site 2002
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Zai Lab Site 2018
      • Contact: Site 2018
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Zai Lab Site 2024
      • Contact: Site 2024
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Not yet recruiting
      • Zai Lab Site 2012
      • Contact: Site 2012
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Zai Lab Site 2006
      • Contact: Site 2006
    • Falls Church, Virginia, United States, 22042
      • Not yet recruiting
      • Zai Lab Site 2008
      • Contact: Site 2008

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation	Drug: ZL-1310; Drug: ZL-1310
Experimental: Dose Expansion: Arm 1; Dose level 1 established from escalation	Drug: ZL-1310; Drug: ZL-1310
Experimental: Dose Expansion: Arm 2; Dose level 2 established from escalation	Drug: ZL-1310; Drug: ZL-1310

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of Treatment Emergent Adverse-Events	Number of subjects with treatment-emergent adverse events (TEAEs)	up to 24 months
Incidence of Serious Adverse Events	Number of subjects with serious adverse events (SAEs)	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR per RECIST 1.1	Objective Response Rate (ORR) per RECIST 1.1	up to 24 months
Duration of Response per RECIST 1.1	Duration of Response per RECIST 1.1	up to 24 months
DCR per RECIST 1.1	Disease Control Rate (DCR) per RECIST 1.1	up to 24 months
Overall Survival	Overall Survival (OS)	up to 24 months
PFS per RECIST 1.1	Progression free survival (PFS) per RECIST 1.1	up to 24 months
Pharmacokinetics (PK): Total Antibody	Total Antibody	up to 24 months
Pharmacokinetics (PK): Unconjugated payloads	Unconjugated payloads	up to 24 months

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.
• Collaborators: Zai Lab (US) LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZL-1310-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No