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Clinical Trials in China / NCT06283719
Recruiting Phase 1/2

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

NCT06283719 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Phase
Phase 1/2
Started
2024-09-02
Last updated
2026-10-19

Condition(s) studied

Small Cell Lung CancerNeuroendocrine Cancer

Investigational drug(s) / intervention(s)

ZG006 →

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

Study summary

This is a multicenter, open-label Phase I/II study consisting of two parts:

Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data.

Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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; * Life expectancy ≥ 3 months; * Participants with histologically or cytologically confirmed advanced solid tumors who also fulfill the following: Part 1: advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma.Part 2: advanced SCLC.Specifically for Part 2 Cohort 1: de-novo SCLC (composite SCLC excluded).Stage 2 restricted to third-line or later.Cohort 2: transformed SCLC.Cohort 3: large-cell neuroendocrine carcinoma of the lung and composite SCLC. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Primary outcome measure(s)

  • Objective response rate (ORR) — up to approximately 2 years
    ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.
  • Overall Survival (OS) — up to approximately 3 years

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality Recruiting

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors Starting soon
ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon
Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer Recruiting
Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors Recruiting
A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma Starting soon

Other trials for the same condition

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) Active, not recruiting
AK112 Combination Therapy as First Line Treatment for Metastatic Digestive System Neuroendocrine Cancer Starting soon
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer. Recruiting
A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy Recruiting
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06283719 on ClinicalTrials.gov ↗ ← All trials in China