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

Last updated: October 17, 2024
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Endometrial Cancer

Treatment

carboplatin

SSGJ-707

paclitaxel

Clinical Study ID

NCT06522828
SSGJ-707-ST-II-02
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Known uncontrolled or symptomatic central nervous system metastatic disease.

  2. Adverse events (with exception of alopecia and fatigue) from any prior anticancertherapy of grade >1 (National Cancer Institute Common terminology Criteria [NCICTCAE] 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 informationwas not intended to contain all considerations relevant to a participant's potentialparticipation in a clinical trial.

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: carboplatin
Phase: 2
Study Start date:
October 10, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Zhou Qi

    Chongqing, Chongqing
    China

    Site Not Available

  • Chongqing Cancer Hospital

    Chongqing,
    China

    Active - Recruiting

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