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

NCT06859775 | Recruiting Phase 1

• 1 other identifier: SHR-A1811-216-CC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent or Metastatic Cervical Cancer

Outcome Measures

Primary Outcomes (3)

• Grade≥3 drug-related adverse events (TRAEs).

  Up to 3 years.

• Grade≥3 drug-related serious adverse events (TRAEs).

  Up to 3 years.

• Objective response rate (ORR).

  Up to 3 years.

Secondary Outcomes (4)

• Duration of response (DOR).

  Up to 3 years.

• Disease control rate (DCR).

  Up to 3 years.

• Progression-free survival (PFS).

  Up to 3 years.

• Overall survival (OS).

  Up to 3 years.

Study Arms (3)

Treatment cohort 1

EXPERIMENTAL

Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection

Treatment cohort 2

EXPERIMENTAL

Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection; Drug: SHR-8068

Treatment cohort 3

EXPERIMENTAL

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

Interventions

SHR-A1811 DRUG

SHR-A1811 injection.

Treatment cohort 1; Treatment cohort 2; Treatment cohort 3

Adebelimab injection DRUG

Adebelimab injection.

Treatment cohort 1; Treatment cohort 2; Treatment cohort 3

Bevacizumab injection DRUG

Bevacizumab injection.

Treatment cohort 1; Treatment cohort 2; Treatment cohort 3

SHR-8068 DRUG

SHR-8068 injection.

Treatment cohort 2; Treatment cohort 3

Cisplatin injection DRUG

Cisplatin injection.

Treatment cohort 3

Carboplatin injection DRUG

Carboplatin injection.

Treatment cohort 3

Eligibility Criteria

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

You may qualify if:

• Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
• Female, aged 18-75 years old.
• Expected survival ≥ 12 weeks.
• Normal function of vital organs.
• 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.
• 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.

You may not qualify if:

• Previous or concomitant other malignancies.
• Severe bone damage caused by bone metastasis from tumours.
• Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
• Those with active tuberculosis.
• Concomitant poorly controlled or severe cardiovascular disease.
• Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
• Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
• Subjects who have had a serious infection within 1 month before the first dose.
• Subjects who have a history of immunodeficiency.
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Uterine Cervical Neoplasms

Interventions

Bevacizumab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Na An

CONTACT

+86-0518-82342973; na.an@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

CN (1)