Advanced Solid Tumors Patients
Conditions
Keywords
Solid Tumors
Brief summary
This study includes two parts, different part has different administration frequencies of SSGJ-706.
Detailed description
This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.
Interventions
Bispecific antibody
Sponsors
Study design
Eligibility
Inclusion criteria
1. Males and/or females over age 18 2. Histologically and/or cytologically documented advanced or metastatic Solid Tumors . 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>=3 months. 5. Signed informed consent form.
Exclusion criteria
1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to SSGJ-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLTs | 12 months | Dose limiting toxicity |
| MTD or MAD | 12 months | maximum tolerated dose or the maximum administered dose if MTD is not reached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The blood concentration of SSGJ-706 | 12 months | PK characteristics |