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RecruitingNCT06654440Updated Dec 10, 2024

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

A Phase 2 interventional study of SHR-A2102 for injection in Advanced Gynecological Malignancy, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Advanced Gynecological Malignancy

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd. is the lead sponsor of 59 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Single Group

    Drug: SHR-A2102 for injection

Interventions

  • DrugSHR-A2102 for injection

    SHR-A2102 for injection

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Assessed by Investigator according to RECIST 1.1 criteria.

    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.

Secondary outcomes

  1. Duration of response (DoR)

    Assessed by Investigator according to RECIST 1.1 criteria.

    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.

  2. Disease control rate (DCR)

    Assessed by Investigator according to RECIST 1.1 criteria.

    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.

  3. Time to response (TTR)

    Assessed by Investigator according to RECIST 1.1 criteria.

    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.

  4. Progression free survival (PFS)

    Assessed by Investigator according to RECIST 1.1 criteria.

    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.

  5. Overall survival (OS)

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

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

  6. 12 month survival rate

    Survival rate within one year.

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

  7. Adverse Events (AEs)

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

    Time frame: Up to approximately 24 months.

  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.

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    • Jihong Liu · Contact
    • Jihong Liu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06654440
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Oct 23, 2024
Start date
Nov 15, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Dec 10, 2024

Study contacts

ZhiFei Lin, M.M
Contact
zhifei.lin.zl3@hengrui.com
18702197991

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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