Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
Conditions
Brief summary
This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.
Interventions
SSGJ-707 is a bispecific antibody against human PD-1 and VEGF
chemotherapy
chemotherapy
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age:18-75 years old 2. Advanced endometrial cancer and platinum-resistant ovarian cancer 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>=12 weeks. 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-707 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 |
|---|---|---|
| Safety and tolerability | 12 months | Safety and tolerability assessed by incidence and severity of adverse events |
| ORR | 12 months | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 24 months | The efficacy end point |
Countries
China