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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: SHR-A1811; Drug: Carboplatin; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06840002

SHR-A1811-216-OC

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
3. At least one measurable lesion conforming to RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 12 weeks.
6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Exclusion criteria

1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
4. With hypertension and cannot be well controlled by antihypertensive drug treatment.
5. Accompanied by poorly controlled or serious cardiovascular diseases.
6. Subjects with serious infection within 1 month before the first medication.
7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Treatment group

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Carboplatin

Drug: SHR-A1811