NCT06592638 A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
| NCT ID | NCT06592638 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06592638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06592638 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06592638 currently recruiting?
Yes, NCT06592638 is actively recruiting participants. Contact the research team at liusc@zelgen.com for enrollment information.
Where is the NCT06592638 trial being conducted?
This trial is being conducted at Orange, United States, Plantation, United States, Lexington, United States, Canton, United States and 2 additional locations.
Who is sponsoring the NCT06592638 clinical trial?
NCT06592638 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The trial plans to enroll 30 participants.
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