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Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian CancerPhase 2NCT06522828

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

A Phase 2 study testing SSGJ-707, carboplatin and paclitaxel in people with Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SSGJ-707, carboplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
10 Oct 2024to Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Signed informed consent form.

Who cannot join

  • 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.
  • 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 locations and contacts

1 site in 1 country.

ZHOU, PhD contact

13708384529

qizhou9128@163.com

China1 site, 1 recruiting

  • Chongqing Cancer Hospital

    Chongqing

    ZHOU QI, PhD, +86 13708384529, qizhou9128@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients

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.

Being tested
SSGJ-707, carboplatin, paclitaxel
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSGJ-707Drug

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

  • carboplatinDrug

    chemotherapy

  • paclitaxelDrug

    chemotherapy

Study groups in NCT06522828
Study groupRoleWhat they receive
SSGJ-707(dose 1)+ carboplatin + paclitaxelExperimentalNot described
Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel
SSGJ-707(dose 2)+ carboplatin + paclitaxelExperimentalNot described
Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel
SSGJ-707(dose 3)+ carboplatin + paclitaxelExperimentalNot described
Receives: Drug: SSGJ-707; Drug: carboplatin; Drug: paclitaxel
SSGJ-707(dose 4)+ paclitaxelExperimentalNot described
Receives: Drug: SSGJ-707; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective response rate

    Measured: 12 months

  2. Safety and tolerability

    Safety and tolerability assessed by incidence and severity of adverse events

    Measured: 12 months

Secondary outcomes (1)

  1. PFS

    The efficacy end point

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start10 Oct 2024
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522828
Sponsor's protocol ID
SSGJ-707-ST-II-02
Status last verified
Oct 2024
First submitted
22 Jul 2024
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SSGJ-707, carboplatin and paclitaxel in people with Advanced/recurrent Endometrial Cancer and Platinum-resistant Ovarian Cancer, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ZHOU, PhD (13708384529, qizhou9128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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