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

NCT06654440 | Recruiting Phase 2

• 1 other identifier: SHR-A2102-208
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Gynecological Malignancy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Assessed by Investigator according to RECIST 1.1 criteria.

  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 (11)

• Duration of response (DoR)

  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)

  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)

  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)

  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)

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

Study Arms (1)

Single Group

EXPERIMENTAL

Drug: SHR-A2102 for injection

Interventions

SHR-A2102 for injection DRUG

SHR-A2102 for injection

Single Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

ZhiFei Lin, M.M

CONTACT

18702197991; zhifei.lin.zl3@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 23, 2024
• Study Start: November 15, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-10

Locations

CN (1)