Treatment of advanced gynecological cancer with SHR-A2102

An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies

This study is testing a new injectable treatment called SHR-A2102 to see if it can help women with advanced gynecological cancer that hasn't improved with standard therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06654440 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of SHR-A2102, an injectable treatment, for patients suffering from advanced gynecological malignancies that have not responded to standard therapies. Participants must have measurable lesions and adequate organ function, and the study aims to determine how well this new treatment works compared to existing options. The trial is designed for female patients who are willing to comply with contraception requirements during and after the treatment period.

Who should consider this trial

Good fit: Ideal candidates are women with recurrent or metastatic gynecological malignancies that have failed standard treatments and have at least one measurable lesion.

Not a fit: Patients with untreated brain metastasis or other active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with advanced gynecological cancer who have exhausted standard treatment options.

How similar studies have performed: While this specific treatment approach is novel, similar studies targeting advanced gynecological cancers have shown promising results in the past.

Eligibility criteria

Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Recurrent or metastatic gynecological malignancies that had failed standard treatments.
3. At least one measurable lesion (RECIST version 1.1).
4. ECOG 0\~ 1.
5. With adequate organ functions.
6. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.

Exclusion Criteria

1. With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
2. Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.
3. Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
4. Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.
5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
6. Had active pulmonary tuberculosis within 1 year prior to enrolment.
7. Known to be allergic to any of the components of SHR-A2102.
8. Were not fit to participate in this study by investigator's judgment.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: ZhiFei Lin, M.M

Conditions Advanced Gynecological Malignancy