Testing ZG006 for small cell lung cancer patients who have not responded to standard treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label Phase 1 clinical study evaluating the safety and dosage of ZG006 in patients with small cell lung cancer (SCLC) who have either failed or are intolerant to existing standard treatments. The study employs a dose escalation design using a '3+3' methodology to determine the maximum tolerated dose (MTD) for future studies. Participants will be monitored for safety and efficacy as the dosage increases. The trial aims to provide a new treatment option for this challenging cancer type.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Zelgen
• Email: liusc@zelgen.com
• Phone: +86-02158942758

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.