Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
About this trial
This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the study and voluntarily sign the informed consent form;
Male or female 18~75 years of age;
Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), who had no standard treatment available, or were intolerant to standard treatments;
Archival tissue sample or fresh biopsy tissue sample must be available for DLL3 detection;
Disqualifiers
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry.
The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30g/L; Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min; INR > 1.5 or APTT > 1.5×ULN;
Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of central nervous system (CNS) metastases; Note: Not applicable to the following conditions: subjects with stable CNS metastases;
Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
Trial design
Design model
Sequential
Treatments tested in this trial
ZG006
Biological/VaccineZG006 will be administered as an intravenous (IV) infusion.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of dose-limiting toxicity (DLT)
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
Time frame
Up to 28 days2
Maximum Tolerated Dose (MTD) of ZG006
Time frame
Up to approximately 1 year3
Determine the Recommended Phase 2 Dose (RP2D)
Time frame
Up to approximately 1 year4
Number of participants with adverse events (AEs)
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
Time frame
Up to approximately 2 yearSecondary outcomes
1
Objective response rate (ORR)
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Time frame
Up to approximately 2 year2
Duration of response (DOR)
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 frame
Up to approximately 2 year3
disease control rate (DCR)
Time frame
Up to approximately 2 year4
Maximum plasma concentration (Cmax) of ZG006
Time frame
Baseline and up to approximately 1 yearSponsors and contacts
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Source ClinicalTrials.gov