Clinical trial NCT06211023: A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer
Official title: An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. Be able to provide fresh or archived tumour tissue.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. At least one measurable lesion according to RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
4. Subjects with active hepatitis B or active hepatitis C;
5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.

Primary outcomes:
measure: Objective Response Rate Assessed by Investigator According to RECIST v1.1
timeFrame: Screening up to study completion, an average of 1 year
Secondary outcomes:
measure: Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1
timeFrame: Screening up to study completion, an average of 1 year
measure: Overall Survival (OS)
timeFrame: Screening up to study completion, an average of 1 year
measure: CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria
timeFrame: Screening up to study completion, an average of 1 year
Other outcomes:
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