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

ConditionRecurrent or Metastatic Cervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1811

    Drug

    SHR-A1811 injection.

  • Adebelimab injection

    Drug

    Adebelimab injection.

  • Bevacizumab injection

    Drug

    Bevacizumab injection.

  • SHR-8068

    Drug

    SHR-8068 injection.

  • Cisplatin injection

    Drug

    Cisplatin injection.

  • Carboplatin injection

    Drug

    Carboplatin injection.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Treatment cohort 1Experimental treatment 3 interventions
Group B: Treatment cohort 2Experimental treatment 4 interventions
Group C: Treatment cohort 3Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 3 years.
2

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

Time frame
Up to 3 years.
3

Objective response rate (ORR).

Time frame
Up to 3 years.

Secondary outcomes

1

Duration of response (DOR).

Time frame
Up to 3 years.
2

Disease control rate (DCR).

Time frame
Up to 3 years.
3

Progression-free survival (PFS).

Time frame
Up to 3 years.
4

Overall survival (OS).

Time frame
Up to 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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