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Trial Title:
A Phase 1 Dose Escalation Study of ZG006 in Patients with Small Cell Lung Cancer
NCT ID:
NCT06592638
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ZG006
Description:
ZG006 will be administered as an intravenous (IV) infusion.
Arm group label:
Dose Escalation
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592638
