Clinical trial NCT06859775: SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
Official title: Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Recurrent or Metastatic Cervical Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.


Eligibility criteria: Inclusion Criteria:

1. Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
2. Female, aged 18-75 years old.
3. Expected survival ≥ 12 weeks.
4. Normal function of vital organs.
5. Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
6. Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.

Exclusion Criteria:

1. Previous or concomitant other malignancies.
2. Severe bone damage caused by bone metastasis from tumours.
3. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
4. Those with active tuberculosis.
5. Concomitant poorly controlled or severe cardiovascular disease.
6. Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
7. Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
8. Subjects who have had a serious infection within 1 month before the first dose.
9. Subjects who have a history of immunodeficiency.
10. As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.

Primary outcomes:
measure: Grade≥3 drug-related adverse events (TRAEs).
timeFrame: Up to 3 years.
measure: Grade≥3 drug-related serious adverse events (TRAEs).
timeFrame: Up to 3 years.
measure: Objective response rate (ORR).
timeFrame: Up to 3 years.
Secondary outcomes:
measure: Duration of response (DOR).
timeFrame: Up to 3 years.
measure: Disease control rate (DCR).
timeFrame: Up to 3 years.
measure: Progression-free survival (PFS).
timeFrame: Up to 3 years.
measure: Overall survival (OS).
timeFrame: Up to 3 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: