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

Phase 1

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: ZG006

• Registration Number: NCT06592638
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation	ZG006	-

Primary Outcome Measures

Name	Time	Method
The incidence of dose-limiting toxicity (DLT)	Up to 28 days	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
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)	Approximately 2 years	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
Number of participants with serious adverse events (SAEs)	Approximately 2 years
Incidence of abnormal laboratory results	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Approximately 2 years	ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Duration of response (DOR)	Approximately 2 years	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
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

Trial Locations

Locations (2)

Zelgen Site 102; 🇺🇸 Plantation, Florida, United States

Zelgen Site 101; 🇺🇸 Canton, Ohio, United States