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 | Recruiting Phase 1

• 1 other identifier: ZG006-002
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer; Neuroendocrine Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.

  up to approximately 2 years

Secondary Outcomes (4)

• Number of participants with adverse events (AEs)

  Up to approximately 2 years

• Number of participants with serious adverse events (SAEs)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

Study Arms (2)

Part1 ：Dose Escalation

EXPERIMENTAL

A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.

Biological: ZG006

Part2 ：Dose Expansion

EXPERIMENTAL

Part 2 consists of three cohorts. Cohort 1 is divided into two stages: Stage 1 is for dose optimization: approximately 30 patients will be enrolled in each of the two preliminary RP2D groups; the better-performing dose will be selected for Stage 2 based on emerging data. Stage 2 is the pivotal, registrational study, intended to enroll patients with advanced small-cell lung cancer who are in third-line or later lines of therapy.

Biological: ZG006

Interventions

ZG006 BIOLOGICAL

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

Part1 ：Dose Escalation; Part2 ：Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Hewen Yin

CONTACT

+86-0512-57309965; yinhw@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: September 2, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)