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

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

Trial Details

NCT ID

NCT06283719

Phase

PHASE1 / PHASE2

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

RECRUITING

Cancer Type

Adenocarcinoma Lung Cancer

Interventions

• ZG006

Locations (sample)

• Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility 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;

For full eligibility, visit ClinicalTrials.gov.

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