No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
Who this trial is looking for
This trial is looking for patients with small cell lung cancer who have not responded to or cannot tolerate standard treatments. Participants will receive the experimental drug ZG006 while doctors monitor how well it works and any side effects.
Are You a Good Fit for This Trial?
Rules you outActive infectionSevere allergic reactions
You may be able to join if
I have small cell lung cancer.
I have not responded to or cannot tolerate standard treatments.
I have a tissue sample that tests positive for DLL3.
I expect to live for at least 3 months.
I have a performance status of 0 or 1.
I will use reliable contraception during and at least 6 months after treatment.
You may not be able to join if
I received chemotherapy, biotherapy, or targeted therapy within the last 4 weeks.
I received local palliative radiotherapy or small molecule therapy within the last 2 weeks.
I took systemic immunosuppressive medications within the last 14 days.
I received any vaccines within the last 4 weeks.
I had a blood transfusion or similar treatments in the last 14 days.
I have a history of severe allergic reactions to antibodies.
I am currently pregnant or nursing.
The doctor feels I am unsuitable for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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…
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.
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