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A Study to Evaluate SSGJ-707 in Advanced Gynecologic Cancer Patients

A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522828
Enrollment
80
Registered
2024-07-26
Start date
2024-10-10
Completion date
2026-08-31
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer

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

DRUGcarboplatin

chemotherapy

DRUGpaclitaxel

chemotherapy

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Safety and tolerability12 monthsSafety and tolerability assessed by incidence and severity of adverse events
ORR12 monthsObjective response rate

Secondary

MeasureTime frameDescription
PFS24 monthsThe efficacy end point

Countries

China

Contacts

Primary ContactZHOU, PhD
qizhou9128@163.com13708384529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026