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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neuroendocrine Carcinoma

Treatments: Biological: ZG006

Study type: Interventional

Funder types: Industry

Identifiers

NCT06440057

ZG006-003

Details and patient eligibility

About

This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg.

Treatment:

Biological: ZG006

Dose Expansion

Experimental group

Description:

Participants will receive the RP2D identified in Dose Escalation Study .

Treatment:

Biological: ZG006