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

Part of paid clinical trials in Duarte, California.

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT06179069
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZL-1310 — DRUG
    Drug: ZL-1310
  • Atezolizumab — DRUG
    Drug Atezolizumab
  • Carboplatin — DRUG
    Drug Carboplatin

Study Details

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

Key Dates

First listed
Dec 21, 2023
Start date
Jan 23, 2024
Status verified
Mar 2026
Primary completion
May 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
339 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Part 1A
    ZL-1310 as a single-agent
  • Experimental: Dose Expansion: Part 1B
    ZL-1310 in combination with Atezolizumab
  • Experimental: Dose Escalation: Part 1C
    ZL-1310 in combination with Atezolizumab and Carboplatin as induction and followed by ZL-1310 and Atezolizumab as maintenance
  • Experimental: Dose Expansion: Arm 1 (Part 2)
    Dose level 1 of ZL-1310 established from single-agent dose-escalation
  • Experimental: Dose Expansion: Arm 2 (Part 2)
    Dose level 2 of ZL-1310 established from single-agent dose escalation
  • Experimental: Dose Extension: Arm 1 (Part 2)
    ZL-1310 as a single agent
  • Experimental: Doublet Dose Optimization: Arm 1 (Part 3A)
    Dose level 1 of ZL-1310 established from single agent dose escalation, in combination with Atezolizumab
  • Experimental: Doublet Dose Optimization: Arm 2 (Part 3A)
    Dose level 2 of ZL-1310 established from single agent dose escalation in combination with Atezolizumab
  • Experimental: Triplet Dose Optimization: Arm 1 (Part 4A)
    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
  • Experimental: Triplet Dose Optimization: Arm 2 (Part 4A)
    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
  • Experimental: Dose Extension: Part 2-1
    single-agent dose extension for Post-anti-DLL3
  • Experimental: Doublet Dose Extension: Part 3B
    Doublet dose extension for 1L maintenance only OR 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.
  • Experimental: Triplet Dose Extension: Part 4B
    Triplet dose extension for 1L induction + maintenance; to be initiated at the discretion of the sponsor based on the available emerging data.

Primary Outcome Measure

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) [ Time Frame: up to 24 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Yale Cancer CenterNew HavenConnecticut06519-
Sarah Cannon Research InstituteSarasotaFlorida34232-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Duke UniversityDurhamNorth Carolina27710-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
University of Pittsburgh Hillman Cancer CenterPittsburghPennsylvania15232-
Medical University of South CarolinaCharlestonSouth Carolina29425-
NEXT VirginiaFairfaxVirginia22031-

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By research site
City of Hope· Duarte, CAYale Cancer Center· New Haven, CTSarah Cannon Research Institute· Sarasota, FLBarbara Ann Karmanos Cancer Institute· Detroit, MIHackensack University Medical Center· Hackensack, NJRoswell Park Comprehensive Cancer Center· Buffalo, NY

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