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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer

Treatments: Drug: SSGJ-707; Drug: paclitaxel; Drug: carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06522828

SSGJ-707-ST-II-02

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

SSGJ-707(dose 1)+ carboplatin + paclitaxel

Experimental group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: SSGJ-707

SSGJ-707(dose 2)+ carboplatin + paclitaxel

Experimental group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: SSGJ-707

SSGJ-707(dose 3)+ carboplatin + paclitaxel

Experimental group

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: SSGJ-707

SSGJ-707(dose 4)+ paclitaxel

Experimental group

Treatment:

Drug: paclitaxel

Drug: SSGJ-707