Clinical trial NCT06592638: A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
Official title: A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \&amp;gt; 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.

Primary outcomes:
measure: The incidence of dose-limiting toxicity (DLT)
timeFrame: Up to 28 days
measure: Maximum Tolerated Dose (MTD) of ZG006
timeFrame: Approximately 2 years
measure: Determine the Recommended Phase 2 Dose (RP2D)
timeFrame: Approximately 2 years
measure: Number of participants with adverse events (AEs)
timeFrame: Approximately 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Approximately 2 years
measure: Incidence of abnormal laboratory results
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Approximately 2 years
measure: Duration of response (DOR)
timeFrame: Approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Approximately 2 years
measure: Maximum plasma concentration (Cmax) of ZG006
timeFrame: Approximately 2 years
measure: Time to peak concentration (Tmax)
timeFrame: Approximately 2 years
measure: AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006
timeFrame: Approximately 2 years
measure: Terminal phase half-life (t1/2) of ZG006
timeFrame: Approximately 2 years
measure: Detection of anti-drug antibodies (ADA)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Zelgen Site 102
state: Florida
city: Canton
country: United States
facility: Zelgen Site 101
state: Ohio
Study officials:
References: