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

Phase 2

Recruiting

• Conditions: Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
• Interventions: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT06522828
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Status Verified: 2024-10
• Study Start: 2024-10-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SSGJ-707(dose 3)+ carboplatin + paclitaxel	SSGJ-707	-
SSGJ-707(dose 1)+ carboplatin + paclitaxel	carboplatin	-
SSGJ-707(dose 2)+ carboplatin + paclitaxel	SSGJ-707	-
SSGJ-707(dose 4)+ paclitaxel	SSGJ-707	-
SSGJ-707(dose 1)+ carboplatin + paclitaxel	SSGJ-707	-
SSGJ-707(dose 1)+ carboplatin + paclitaxel	paclitaxel	-
SSGJ-707(dose 2)+ carboplatin + paclitaxel	carboplatin	-
SSGJ-707(dose 2)+ carboplatin + paclitaxel	paclitaxel	-
SSGJ-707(dose 3)+ carboplatin + paclitaxel	carboplatin	-
SSGJ-707(dose 3)+ carboplatin + paclitaxel	paclitaxel	-
SSGJ-707(dose 4)+ paclitaxel	paclitaxel	-

Primary Outcome Measures

Name	Time	Method
ORR	12 months	Objective response rate
Safety and tolerability	12 months	Safety and tolerability assessed by incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	The efficacy end point

Trial Locations

Locations (1)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, China