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NCT Number: NCT06654440

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

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Jihong Liu

CONTACT

Jihong Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-A2102 for Injection

Drug

SHR-A2102 for injection

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

    Assessed by Investigator according to RECIST 1.1 criteria.

Secondary outcomes

  1. Duration of response (DoR)

    Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

    Assessed by Investigator according to RECIST 1.1 criteria.

  2. Disease control rate (DCR)

    Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

    Assessed by Investigator according to RECIST 1.1 criteria.

  3. Time to response (TTR)

    Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

    Assessed by Investigator according to RECIST 1.1 criteria.

  4. Progression free survival (PFS)

    Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.

    Assessed by Investigator according to RECIST 1.1 criteria.

  5. Overall survival (OS)

    Time frame: follow up once every 60 days. Up to approximately 36 months.

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.

  6. 12 month survival rate

    Time frame: follow up once every 60 days. Up to approximately 24 months.

    Survival rate within one year.

  7. Adverse Events (AEs)

    Time frame: Up to approximately 24 months.

    Include incidence,grade(judged according to NCI-CTCAE V5.0 standards).

  8. PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.

    Time frame: Up to approximately 24 months.

  9. PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.

    Time frame: Up to approximately 24 months.

  10. ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.

    Time frame: Up to approximately 24 months.

  11. Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.

    Time frame: Up to approximately 24 months.

Study contacts

Contact information is provided by the study sponsor or research team.

ZhiFei Lin, M.M

CONTACT

[email protected]

18702197991

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.