Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT07231445
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG006 — DRUG
    ZG006 will be administered as an IV infusion.
  • Serplulimab — DRUG
    Serplulimab will be administered as an IV infusion.

Study Details

This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.

Key Dates

Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1：Group A
    ZG006 Q3W
  • Experimental: Part 1：Group B
    ZG006 Q3W

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting toxicities (DLTs) [ Time Frame: Up to Day 28 ]

Central Contacts

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