Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGZG006
ZG006 will be administered as an intravenous (IV) infusion.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of dose-limiting toxicity (DLT) | Up to 28 days | An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria |
| Maximum Tolerated Dose (MTD) of ZG006 | Approximately 2 years | — |
| Determine the Recommended Phase 2 Dose (RP2D) | Approximately 2 years | — |
| Number of participants with adverse events (AEs) | Approximately 2 years | The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 |
| Number of participants with serious adverse events (SAEs) | Approximately 2 years | — |
| Incidence of abnormal laboratory results | Approximately 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | Approximately 2 years | DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause |
| Time to peak concentration (Tmax) | Approximately 2 years | — |
| Disease control rate (DCR) | Approximately 2 years | — |
| Terminal phase half-life (t1/2) of ZG006 | Approximately 2 years | — |
| Detection of anti-drug antibodies (ADA) | Approximately 2 years | — |
| AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006 | Approximately 2 years | — |
| Maximum plasma concentration (Cmax) of ZG006 | Approximately 2 years | — |
| Objective response rate (ORR) | Approximately 2 years | ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. |
Countries
United States
Contacts
Primary ContactZelgen
Outcome results
None listed