NCT07051486

Brief Summary

This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Oct 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Oct 2025Aug 2026

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

November 17, 2025

Status Verified

October 1, 2025

Enrollment Period

4 months

First QC Date

June 26, 2025

Last Update Submit

November 13, 2025

Conditions

Recurrent or Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) assessed by Independent Review Committee (IRC)

    Up to 2 years.

Secondary Outcomes (11)

  • Overall survival (OS) assessed by Independent Review Committee (IRC)

    Up to 2 years.

  • Overall survival (OS) assessed by investigators

    Up to 2 years.

  • Progression free survival (PFS) assessed by Independent Review Committee (IRC)

    Up to 2 years.

  • Progression free survival (PFS) assessed by investigators

    Up to 2 years.

  • Duration of response (DoR) assessed by Independent Review Committee (IRC)

    Up to 2 years.

  • +6 more secondary outcomes

Study Arms (1)

SHR-A1811 Group

EXPERIMENTAL
Drug: SHR-A1811 Injection

Interventions

SHR-A1811 InjectionDRUG

SHR-A1811 for injection.

SHR-A1811 Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
  • Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
  • Cervical cancer confirmed by tissue or cytological pathology.
  • Expected survival ≥ 12 weeks.
  • Normal function of important organs.
  • Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.

You may not qualify if:

  • Subjects with known untreated or active central nervous system (CNS) tumor metastases.
  • Subjects with other malignant tumors in the past or at the same time.
  • Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
  • Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
  • Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
  • Subjects with known lung damage caused by concurrent lung diseases.
  • Subjects with active pulmonary tuberculosis.
  • Subjects with poorly controlled or severe cardiovascular diseases.
  • Subjects with arterial/venous thrombotic events within 1 month before enrollment.
  • Subjects who had a serious infection within 1 month before enrollment.
  • History of immunodeficiency, including positive HIV test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

RECRUITING

Shandong University Qilu Hospital

Jinan, Shandong, 250063, China

RECRUITING

MeSH Terms

Conditions

RecurrenceUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Na An

CONTACT

+86-0518-82342973na.an@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

June 26, 2025

First Posted

July 4, 2025

Study Start

October 11, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 17, 2025

Record last verified: 2025-10

Locations

CN(2)