Health TrialsbyHealthPanel

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

ConditionAdvanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SSGJ-707

    Drug

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

  • carboplatin

    Drug

    chemotherapy

  • paclitaxel

    Drug

    chemotherapy

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: SSGJ-707(dose 1)+ carboplatin + paclitaxelExperimental treatment 3 interventions
Group B: SSGJ-707(dose 2)+ carboplatin + paclitaxelExperimental treatment 3 interventions
Group C: SSGJ-707(dose 3)+ carboplatin + paclitaxelExperimental treatment 3 interventions
Group D: SSGJ-707(dose 4)+ paclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate

Time frame
12 months
2

Safety and tolerability

Safety and tolerability assessed by incidence and severity of adverse events

Time frame
12 months

Secondary outcomes

1

PFS

The efficacy end point

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now