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ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

ConditionsSmall Cell Lung CancerNeuroendocrine Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Male or female 18-70 years of age.

Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.

Eastern Cooperative Oncology Group (ECOG) 0 to 1.

Disqualifiers

The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ZG006

    Drug

    ZG006 will be administered as an intravenous (IV) infusion.

  • ZG005

    Drug

    ZG005 will be administered as an intravenous (IV) infusion.

Treatment groups

350 Participants
are divided into 3 treatment groups
Group A: Phase Ib: Part1-Dose EscalationExperimental treatment 2 interventions
Group B: Phase Ib: Part2-Dose ExpansionExperimental treatment 2 interventions
Group C: Phase IIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Who Experienced Dose-limiting Toxicity (DLT)

Time frame
up to 28 days
2

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

Time frame
Up to 2 years
3

Objective Response Rate (ORR)

The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

Time frame
Up to 2 years

Secondary outcomes

1

Duration of Response (DOR)

Time frame
Up to 2 years
2

Disease Control Rate (DCR)

Time frame
Up to 2 years
3

Progression-free Survival (PFS)

Time frame
Up to 2 years
4

Overall Survival (OS)

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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