Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian CancerPhase 2NCT06522828
A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients
A Phase 2 study testing SSGJ-707, carboplatin and paclitaxel in people with Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
- What is being tested?
- SSGJ-707, carboplatin and paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to Aug 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chongqing Cancer Hospital
Chongqing
ZHOU QI, PhD, +86 13708384529, qizhou9128@163.com
About this study
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients
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.
- Being tested
- SSGJ-707, carboplatin, paclitaxel
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-707Drug
SSGJ-707 is a bispecific antibody against human PD-1 and VEGF
carboplatinDrug
chemotherapy
paclitaxelDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-707(dose 1)+ carboplatin + paclitaxel | Experimental | Not described Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| SSGJ-707(dose 2)+ carboplatin + paclitaxel | Experimental | Not described Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| SSGJ-707(dose 3)+ carboplatin + paclitaxel | Experimental | Not described Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel |
| SSGJ-707(dose 4)+ paclitaxel | Experimental | Not described Receives: Drug: SSGJ-707; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 12 months
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
Measured: 12 months
Secondary outcomes (1)
PFS
The efficacy end point
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start10 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522828
- Sponsor's protocol ID
- SSGJ-707-ST-II-02
- Status last verified
- Oct 2024
- First submitted
- 22 Jul 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No