RecruitingPhase 2NCT06522828

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


Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

80 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

Interventions

DRUGSSGJ-707

SSGJ-707 is a bispecific antibody against human PD-1 and VEGF

DRUGcarboplatin

chemotherapy

DRUGpaclitaxel

chemotherapy


Locations(1)

Chongqing Cancer Hospital

Chongqing, China

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NCT06522828