A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer

A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer

This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard "3+3" design will be used to assess the MTD/ recommended dose for the subsequent studies.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: ZG006

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zelgen; Phone Number: +86-02158942758; Email: liusc@zelgen.com

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Not yet recruiting
      • Zelgen Site 105
  • Florida
    • Plantation, Florida, United States, 33322
      • Recruiting
      • Zelgen Site 102
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • Zelgen Site 103
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Zelgen Site 101
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Zelgen Site 104
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Zelgen Site 106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;
• Tissue sample positive for DLL3 expression;
• Life expectancy ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.

Exclusion Criteria:

• Patients having received any of the following treatments:

  • Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;
  • Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry;
  • Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
• Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;
• A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;
• Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection);
• Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;
• A female who is pregnant or nursing;
• Patients were deemed unsuitable for participating in the study by the investigator for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation	Drug: ZG006; ZG006 will be administered as an intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of dose-limiting toxicity (DLT)	An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria	Up to 28 days
Maximum Tolerated Dose (MTD) of ZG006		Approximately 2 years
Determine the Recommended Phase 2 Dose (RP2D)		Approximately 2 years
Number of participants with adverse events (AEs)	The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0	Approximately 2 years
Number of participants with serious adverse events (SAEs)		Approximately 2 years
Incidence of abnormal laboratory results		Approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 2 years
Duration of response (DOR)	DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause	Approximately 2 years
Disease control rate (DCR)		Approximately 2 years
Maximum plasma concentration (Cmax) of ZG006		Approximately 2 years
Time to peak concentration (Tmax)		Approximately 2 years
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006		Approximately 2 years
Terminal phase half-life (t1/2) of ZG006		Approximately 2 years
Detection of anti-drug antibodies (ADA)		Approximately 2 years

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZG006US001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No