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Trial Title:
A Study of ZG005 in Patients With Advanced Solid Tumors
NCT ID:
NCT06233292
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ZG005 Powder for Injection
Description:
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.
Arm group label:
Part 1: Dose Escalation
Other name:
ZG005
Intervention type:
Biological
Intervention name:
ZG005 Powder for Injection
Description:
Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy, intravenous infusion, once every 3
weeks.
Arm group label:
Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy
Other name:
ZG005
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanmei Lou
Email:
louhm@zjcc.org.cn
Start date:
June 17, 2022
Completion date:
January 2026
Lead sponsor:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06233292
