Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZGGS18 for Injection, ZG005 for Injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer
Overview
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.
Interventions
- Biological ZGGS18 for Injection
Intravenous infusion - Biological ZG005 for Injection
Intravenous infusion
Primary outcome measures
- Dose limited toxicity(DLT) [Time frame: up to 21 days]
- Adverse Event (AE) [Time frame: Up to 2 years]
- Maximum tolerated dose(MTD) [Time frame: Up to 1 years]
- Recommended phase II dose(RP2D) [Time frame: Up to 1 years]
Secondary outcome measures (2)
- Objective response rate (ORR) [Time frame: Up to 2 years]
- Immunogenicity [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- Fully understand this study and voluntarily sign the ICF.
- Age 18-75 years, no gender restriction.
- Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.
Exclusion criteria
- Medical history, CT scan, or MRI indicates the presence of CNS metastases.
- Other malignancies within 5 years.
- Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06938880 · ZGGS18-ZG005-001