A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
SHR-A1811 Injection
DrugSHR-A1811 for injection.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: SHR-A1811 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Time frame
Up to 2 years.Secondary outcomes
1
Overall survival (OS) assessed by Independent Review Committee (IRC)
Time frame
Up to 2 years.2
Overall survival (OS) assessed by investigators
Time frame
Up to 2 years.3
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame
Up to 2 years.4
Progression free survival (PFS) assessed by investigators
Time frame
Up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov