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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

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with histologically or cytologically confirmed ES-SCLC.

Fully understand the study and voluntarily sign the informed consent form;

Male or female 18~75 years of age;

Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;

Disqualifiers

Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG006

    Drug

    ZG006 will be administered as an IV infusion.

  • Serplulimab

    Drug

    Serplulimab will be administered as an IV infusion.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Part 1：Group AExperimental treatment 2 interventions
Group B: Part 1：Group BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Dose-limiting toxicities (DLTs)

Time frame
Up to Day 28
2

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 2 Years

Secondary outcomes

1

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time frame
Up to 2 Years
2

Maximum Serum Concentration (Cmax) of ZG006

Time frame
Up to 2 Years
3

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006

Time frame
Up to 2 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
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