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

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT06522828
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SSGJ-707 — DRUG
    SSGJ-707 is a bispecific antibody against human PD-1 and VEGF
  • carboplatin — DRUG
    chemotherapy
  • paclitaxel — DRUG
    chemotherapy

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
Oct 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SSGJ-707(dose 1)+ carboplatin + paclitaxel
  • Experimental: SSGJ-707(dose 2)+ carboplatin + paclitaxel
  • Experimental: SSGJ-707(dose 3)+ carboplatin + paclitaxel
  • Experimental: SSGJ-707(dose 4)+ paclitaxel

Primary Outcome Measure

ORR [ Time Frame: 12 months ]

Central Contacts