A Study of ZG005 in Patients With Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
About this trial
This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the study and voluntarily sign the informed consent form.
Male or female 18-70 years of age;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
Life expectancy ≥ 3 months;
Disqualifiers
Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
Any other malignancy within 5 years.
Trial design
Design model
Sequential
Treatments tested in this trial
ZG005 Powder for Injection
Biological/VaccineThe dose groups of ZG005 for dose escalations are set as 0.3 mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, and 20mg/kg, intravenous infusion, once every 3 weeks.
ZG005 Powder for Injection
Biological/VaccineRecommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3 weeks.
Treatment groups
484 Participants
are divided into 2 treatment groupsGroup A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicities (DLT)
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Time frame
Up to 21Days2
Adverse Event (AE)
Number of participants with adverse events that are related to treatment
Time frame
Up to 24 Months3
Objective Response Rate
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time frame
Up to 24 Months4
Maximum tolerated dose (MTD)
During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.
Time frame
Up to 24 MonthsSponsors and contacts
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Source ClinicalTrials.gov