About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Sequential
Treatments tested in this trial
ZGGS18 for Injection
Biological/VaccineIntravenous infusion
ZG005 for Injection
Biological/VaccineIntravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
Dose limited toxicity(DLT)
Incidence and severity of DLT events
Adverse Event (AE)
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Maximum tolerated dose(MTD)
Recommended phase II dose(RP2D)
Secondary outcomes
Objective response rate (ORR)
Objective Response Rate as Assessed by Investigator according to RECIST v1.1
Immunogenicity
Incidence of antidrug antibodies (ADA)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.