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NCT Number: NCT06522828

A Study to Evaluate 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.

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Key information

Conditions

Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SSGJ-707

Drug

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

carboplatin

Drug

chemotherapy

paclitaxel

Drug

chemotherapy

Primary outcomes

  1. ORR

    Time frame: 12 months

    Objective response rate

  2. Safety and tolerability

    Time frame: 12 months

    Safety and tolerability assessed by incidence and severity of adverse events

Secondary outcomes

  1. PFS

    Time frame: 24 months

    The efficacy end point

Study contacts

Contact information is provided by the study sponsor or research team.

ZHOU, PhD

CONTACT

[email protected]

13708384529

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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