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

NCT06592638 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ZG006US001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Objective response rate (ORR)

  Approximately 2 years

• Duration of response (DOR)

  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

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Drug: ZG006

Interventions

ZG006 DRUG

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

Dose Escalation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (6)

Zelgen Site 105

Orange, California, 92868, United States

NOT YET RECRUITING

Zelgen Site 102

Plantation, Florida, 33322, United States

RECRUITING

Zelgen Site 103

Lexington, Kentucky, 40536, United States

RECRUITING

Zelgen Site 101

Canton, Ohio, 44718, United States

RECRUITING

Zelgen Site 104

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

Zelgen Site 106

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zelgen

CONTACT

+86-02158942758; liusc@zelgen.com

Study Design

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

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-04

Locations

US (6)