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Phase 1 ZG006 for Small Cell Lung Cancer

This study is testing a new drug called ZG006 for people with small cell lung cancer. ZG006 is given through an IV (into a vein) and works by targeting specific cancer cells and boosting the immune system. You might be able to join if you have small cell lung cancer that hasn't responded to standard treatments, and your tissue sample shows a specific marker called DLL3. The main goals are to find a safe dose of ZG006 and understand any side effects. This study is currently recruiting participants.

Study design
This is a Phase 1 study, meaning it's an early stage of testing a new drug. It will include about 30 participants and is "open-label," so both you and your doctors will know you are receiving ZG006.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track certain effects for up to 28 days and determine the best dose over approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06592638

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
~30 participants
Updated 2025-08-06 on ClinicalTrials.gov
What's tested:ZG006

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence of dose-limiting toxicity (DLT)
Measured over Up to 28 days
+5 more outcomes measured

Conditions

Small Cell Lung Cancer

Explore related trials

Lung Small Cell CarcinomaDLL3 Gene

Where it's being run

6 sites across 5 states
Ohio2
California1
Florida1
Kentucky1
Texas1

Who to contact

Zelgen
[email protected]
+86-02158942758
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 ZG006Approximately 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 resultsApproximately 2 years