A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

ConditionOvarian Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexFemale

Age18-75

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.

Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.

At least one measurable lesion conforming to RECIST v1.1.

ECOG PS score: 0-1.

Disqualifiers

With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.

Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.

Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.

With hypertension and cannot be well controlled by antihypertensive drug treatment.

Trial design

Design model

Single group

Treatments tested in this trial

SHR-A1811
Drug
SHR-A1811.
Carboplatin
Drug
Carboplatin.
Bevacizumab
Drug
Bevacizumab.
Oxaliplatin for Injection
Drug
Oxaliplatin for injection.
Paclitaxel injection
Drug
Paclitaxel injection.
Doxorubicin hydrochloride liposome injection
Drug
Doxorubicin hydrochloride liposome injection.
Adebrelimab Injection
Drug
Adebrelimab injection.

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Treatment groupExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

Dose limited toxicity (DLT)

Time frame

Up to 21 days.

Recommended phase II dose (RP2D)

Time frame

Up to 21 days.

Objective response rate (ORR)

Time frame