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

Launched by SUZHOU ZELGEN BIOPHARMACEUTICALS CO.,LTD · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ZG006 for patients with small cell lung cancer, particularly those who have not responded well to standard treatments or cannot tolerate them. The study is in its early phase, where researchers will slowly increase the dose of ZG006 to find the highest amount that can be safely given without severe side effects. The trial aims to see how effective this treatment can be for patients, and it will take place at multiple centers in the U.S.

To participate in the trial, patients need to have small cell lung cancer that has not improved with other treatments and must have a tissue sample that shows a specific marker called DLL3. They should expect to be in good overall health, with a life expectancy of at least three months. Additionally, both men and women will need to agree to use reliable contraception during the study and for six months after. The trial is not yet recruiting participants, but it’s an important opportunity for those looking for new treatment options in a challenging situation.

Gender

ALL

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.