CTRI/2026/07/113491尚未招募3 期
An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 23
- 主要终点
- 2. Overall Survival (OS)
研究概览
简要总结
This is a randomized, open-label, active-controlled, multicenter Phase 3 clinical trial to evaluate the efficacy and safety of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
Subjects with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer are planned to be enrolled in the study.
Randomization will be stratified. Eligible subjects will be randomized in a 1:1 ratio to receive either SHR-A1811 (experimental group) or investigator’s choice of chemotherapy (control group), which may include doxorubicin liposome, paclitaxel, topotecan, or gemcitabine. The study will have 28 days of screening period, followed by treatment period, end of treatment and Follow-up. Safety follow up will be done 40 days after the last dose while long term (survival) follow up will be done once every two months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Female, aged 18 to 75 years (inclusive of 18 and 75 years; age calculated as on the date of ICF signing) and has provided voluntary written informed consent.
- •Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- •Documented platinum-resistant recurrence after prior platinum-based therapy (defined as PD during platinum treatment or within lessthan 183 days after the last dose of platinum-based therapy)
- •HER2 expression of IHC 1+, 2+, or 3+
- •At least one measurable lesion as defined by RECIST v1.
- •Lesions previously treated with local therapy may be selected as target lesions if there is clear evidence of significant progression after completion of local treatment.
- •ECOG PS score of 0 to
- •Expected survival of greater than or equal to 12 weeks.
- •Adequate organ function (e.g., bone marrow, liver, kidney) as defined in the study protocol.
- •For female subjects of childbearing potential, a negative pregnancy test result must be confirmed during the screening period.
- •Subjects must agree to use effective contraception and refrain from egg donation during the study participation.
排除标准
- •Histologically confirmed sarcomatous histologic subtype, or mixed tumors containing sarcomatous components.
- •Untreated or active CNS metastases, or a history of or current meningeal metastases.
- •Prior treatment with topoisomerase I inhibitors (including but not limited to irinotecan, topotecan), or treatment with antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor payload, such as Enhertu (DS-8201a) and U3-
- •Receipt of systemic anti-tumor therapy within 4 weeks prior to the initiation of study treatment.
- •For prior treatment with small molecule targeted therapies, the interval between end of treatment and the first dose of study treatment must be at least 5 half-lives of the drug or 7 days.
- •Presence of symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion, or ascites.
- •Receipt of palliative radiotherapy within 7 days prior to the first dose of study treatment.
- •History of or concurrent other malignancies, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid cancer, or other malignancies that have been adequately treated and cured for greater than and equall to 3 years prior to randomization and for which there is documented evidence of no recurrence or metastasis.
结局指标
主要结局
2. Overall Survival (OS)
1. Progression Free Survival (PFS) assessed by the Independent Review Committee (IRC) based on RECIST v1.1.
次要结局
- IRC-assessed ORR, DoR, and DCR per RECIST v1.1
- Investigator-assessed PFS, ORR, DoR, and DCR per RECIST v1.1
- CA-125 RR assessed based on GCIG CA-125 criteria
- RR assessed based on CA-125 RR and IRC ORR
- AEs and SAEs, including type, incidence, severity (graded according to the NCI-CTCAE v6.0), and relation to study drug
- Laboratory parameter abnormalities, including type, incidence, and grading (per NCI-CTCAE v6.0)
- Vital signs, electrocardiogram (ECG), and ECOG PS score
- Serum concentrations of the toxin-conjugated antibody (SHR-A1811) and the free toxin SHR169265
- Presence of anti-SHR-A1811 antibodies (ADAs) and neutralizing antibodies (NAbs)
研究者
研究点 (23)
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