Advanced Solid Tumor
Conditions
Brief summary
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
BIOLOGICALZGGS18 for Injection
Intravenous infusion
BIOLOGICALZG005 for Injection
Intravenous infusion
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limited toxicity(DLT) | up to 21 days | Incidence and severity of DLT events |
| Adverse Event (AE) | Up to 2 years | Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations. |
| Maximum tolerated dose(MTD) | Up to 1 years | — |
| Recommended phase II dose(RP2D) | Up to 1 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 2 years | Objective Response Rate as Assessed by Investigator according to RECIST v1.1 |
| Immunogenicity | Up to 2 years | Incidence of antidrug antibodies (ADA) |
Countries
China
Contacts
Primary ContactSiqi Jia
Outcome results
None listed