Evaluating SSGJ-707 for advanced gynecologic cancers
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
This study is testing if adding a new drug called SSGJ-707 to standard chemotherapy can help people with advanced endometrial and platinum-resistant ovarian cancer feel better and respond to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT06522828 on ClinicalTrials.gov |
What this trial studies
This open, multicenter Phase II clinical study investigates the combination of SSGJ-707 with chemotherapy in patients suffering from advanced or recurrent endometrial cancer and platinum-resistant ovarian cancer. The primary focus is to assess the safety, tolerability, and antitumor activity of SSGJ-707 when used alongside carboplatin and paclitaxel. Participants will be monitored for their response to treatment and any adverse effects experienced during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced endometrial cancer or platinum-resistant ovarian cancer and an ECOG performance status of 0-1.
Not a fit: Patients with uncontrolled central nervous system metastases or significant adverse events from prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gynecologic cancers that are difficult to treat.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating advanced gynecologic cancers with novel agents.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing
- Chongqing Cancer Hospital — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: ZHOU, PhD
- Email: qizhou9128@163.com
- Phone: 13708384529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.