A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy

Официальное название

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

Обзор

The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.

Вмешательства

• Препарат SHR-A2102 for injection
  SHR-A2102 for injection

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.]

Вторичные конечные точки (11)

• Duration of response (DoR) [Срок оценки: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.]
• Disease control rate (DCR) [Срок оценки: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.]
• Time to response (TTR) [Срок оценки: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.]
• Progression free survival (PFS) [Срок оценки: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.]
• Overall survival (OS) [Срок оценки: follow up once every 60 days. Up to approximately 36 months.]
• 12 month survival rate [Срок оценки: follow up once every 60 days. Up to approximately 24 months.]
• Adverse Events (AEs) [Срок оценки: Up to approximately 24 months.]
• PK traits of SHR-A2102: Plasma concentrations of SHR-A2102. [Срок оценки: Up to approximately 24 months.]
• PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites. [Срок оценки: Up to approximately 24 months.]
• ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. [Срок оценки: Up to approximately 24 months.]
• Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. [Срок оценки: Up to approximately 24 months.]

Критерии участия

Критерии включения

• Participate in the study voluntarily, sign the informed consent form.
• Recurrent or metastatic gynecological malignancies that had failed standard treatments.
• At least one measurable lesion (RECIST version 1.1).
• ECOG 0\~ 1.
• With adequate organ functions.
• 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.

Критерии исключения

• With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.
• 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.
• Had previously received antibody drug conjugates containing topoisomerase I inhibitors.
• 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.
• Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.
• Had active pulmonary tuberculosis within 1 year prior to enrolment.
• Known to be allergic to any of the components of SHR-A2102.
• Were not fit to participate in this study by investigator's judgment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06654440 · SHR-A2102-208

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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