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

NCT ID: NCT06522828

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2026-08-31

Brief Summary

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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

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Conditions

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Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSGJ-707(dose 1)+ carboplatin + paclitaxel

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

chemotherapy

paclitaxel

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 2)+ carboplatin + paclitaxel

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

chemotherapy

paclitaxel

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 3)+ carboplatin + paclitaxel

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

chemotherapy

paclitaxel

Intervention Type DRUG

chemotherapy

SSGJ-707(dose 4)+ paclitaxel

Group Type EXPERIMENTAL

SSGJ-707

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

chemotherapy

Interventions

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SSGJ-707

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

Intervention Type DRUG

carboplatin

chemotherapy

Intervention Type DRUG

paclitaxel

chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chongqing Cancer Hospital

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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ZHOU, PhD

Role: CONTACT

13708384529

Facility Contacts

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ZHOU QI, PhD

Role: primary

+86 13708384529

Other Identifiers

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SSGJ-707-ST-II-02

Identifier Type: -

Identifier Source: org_study_id

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