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

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

This study is testing a new treatment called ZG006 for people with small cell lung cancer who haven't had success with standard treatments to see if it can help them.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, prednisone
• Locations: 6 sites (Orange, California and 5 other locations)
• Trial ID: NCT06592638 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with small cell lung cancer who have failed or are intolerant to standard treatments and have a positive tissue sample for DLL3 expression.

Not a fit: Patients who have recently received certain treatments or have systemic immunosuppressive conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new therapeutic option for patients with small cell lung cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting DLL3 expression in small cell lung cancer have shown promise in preliminary findings.

Eligibility criteria

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 this trial is running

Orange, California and 5 other locations

• Zelgen Site 105 — Orange, California, United States (Not_yet_recruiting)
• 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 104 — Cleveland, Ohio, United States (Not_yet_recruiting)
• Zelgen Site 106 — Houston, Texas, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Zelgen

Conditions Small Cell Lung Cancer