SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Recurrent or Metastatic Cervical Cancer

Treatments: Drug: SHR-8068; Drug: Bevacizumab injection; Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Adebelimab injection; Drug: SHR-A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT06859775

SHR-A1811-216-CC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Treatment cohort 1

Experimental group

Treatment:

Drug: SHR-A1811

Drug: Adebelimab injection

Drug: Bevacizumab injection

Treatment cohort 2

Experimental group

Treatment:

Drug: SHR-A1811

Drug: Adebelimab injection

Drug: Bevacizumab injection

Drug: SHR-8068

Treatment cohort 3

Experimental group

Treatment:

Drug: SHR-A1811

Drug: Cisplatin injection

Drug: Adebelimab injection

Drug: Carboplatin injection

Drug: Bevacizumab injection

Drug: SHR-8068