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Trial Title:
A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
NCT ID:
NCT06522828
Condition:
Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-707
Description:
SSGJ-707 is a bispecific antibody against human PD-1 and VEGF
Arm group label:
SSGJ-707(dose 1)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 2)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 3)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 4)+ paclitaxel
Intervention type:
Drug
Intervention name:
carboplatin
Description:
chemotherapy
Arm group label:
SSGJ-707(dose 1)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 2)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 3)+ carboplatin + paclitaxel
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
chemotherapy
Arm group label:
SSGJ-707(dose 1)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 2)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 3)+ carboplatin + paclitaxel
Arm group label:
SSGJ-707(dose 4)+ paclitaxel
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
ZHOU QI, PhD
Phone:
+86 13708384529
Email:
qizhou9128@163.com
Start date:
October 10, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522828
