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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer; Neuroendocrine Carcinoma

Treatments: Drug: ZG006; Drug: ZG005

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038096

ZG006-ZG005-001

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Life expectancy > 3 months.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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350 participants in 3 patient groups

Phase Ib: Part1-Dose Escalation

Experimental group

Description:

This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.

Treatment:

Drug: ZG005

Drug: ZG006

Phase Ib: Part2-Dose Expansion

Experimental group

Description:

The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Treatment:

Drug: ZG005

Drug: ZG006

Phase II

Experimental group

Description:

Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.

Treatment:

Drug: ZG005

Drug: ZG006