Solid Tumors
Conditions
Brief summary
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.
Interventions
BIOLOGICALZG005 Powder for Injection
The 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.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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; * Histologically or cytologically confirmed diagnosis of advanced solid tumors.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLT) | Up to 21Days | 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. |
| Adverse Event (AE) | Up to 24 Months | Number of participants with adverse events that are related to treatment |
| Objective Response Rate | Up to 24 Months | Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) |
| Maximum tolerated dose (MTD) | Up to 24 Months | 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. |
Countries
China
Contacts
Primary ContactYongsheng Chu
Outcome results
None listed