A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
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: SSGJ-707, carboplatin, paclitaxel.
- Who it may be relevant to
- Registry conditions: Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer. 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 →
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Official title
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
Overview
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
- Drug SSGJ-707
SSGJ-707 is a bispecific antibody against human PD-1 and VEGF - Drug carboplatin
chemotherapy - Drug paclitaxel
chemotherapy
Primary outcome measures
- ORR [Time frame: 12 months]
- Safety and tolerability [Time frame: 12 months]
Secondary outcome measures (1)
- PFS [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Age:18-75 years old
- Advanced endometrial cancer and platinum-resistant ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival >=12 weeks.
- Signed informed consent form.
Exclusion criteria
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- 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).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- 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.
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chongqing Cancer Hospital — Chongqing
Identifiers
NCT: NCT06522828 · SSGJ-707-ST-II-02