NCT07377643招募中3 期
A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2026年2月10日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
研究概览
简要总结
This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inclusion: (1) measurable lesions outside the CNS; (2) no midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastases; (3) stable for at least 4 weeks with no new or enlarging metastases ( clearly confirmed by clinical symptoms, signs, and imaging evidence); (4) have discontinued corticosteroids and/or anticonvulsants for at least 2 weeks prior to the first dose of study drug and have recovered from the acute toxicity of radiotherapy. Whole brain radiotherapy or stereotactic radiotherapy must be completed at least 2 weeks prior to study randomization. CNS lesions should be monitored and examined regularly during the study.
- •Note: CNS lesions will not be considered target lesions.
- •Non-remission of adverse events (AEs) after previous anti-cancer treatment, defined as AEs that have not been relieved to ≤ grade 1 or baseline before enrollment according to NCI-CTCAE v5.0 criteria (except for alopecia and pigmentation). Note: Participants with chronic, stable Grade 2 toxicities (defined as not worsening to >Grade 2 for at least 3 months prior to enrollment and manageable with standard of care) that were considered by the investigator to be related to prior anticancer therapy, e.g., fatigue, insomnia, hypomagnesemia, chemotherapy-induced peripheral neuropathy, hypothyroidism stably controlled by replacement therapy, and hypertension stably controlled below 160/100 mmHg by antihypertensives, were eligible for study entry.
- •Tumor invades surrounding important tissues and organs (such as mediastinal great vessels, superior vena cava and inferior vena cava, pericardium, heart, trachea, esophagus, etc.).
- •Bleeding within 3 months prior to the first dose of study treatment that is life-threatening and requires blood transfusion or invasive treatment.
- •Symptomatic abdominopelvic fluid collections, pleural effusions, or pericardial effusions requiring intervention (participants with stable controlled effusions, defined as clinically asymptomatic effusions that do not increase significantly with drain removal or no drainage, for at least 7 days, are allowed).
- •Participants with varices in the esophagus or stomach that require immediate intervention (e.g., ligation or sclerotherapy), or who are considered by the investigator or a gastroenterologist or hepatologist to be at high risk for bleeding, have evidence of portal hypertension (including splenomegaly on imaging), or have a history of variceal bleeding, must have endoscopic assessment within 3 months prior to the first start of study treatment.
- •Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis and abdominal abscess), or a history of extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. Note: The digestive tract refers to the muscular tube from the oral cavity to the anal canal, including the oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, and ileum), large intestine (cecum, appendix, colon, and rectum), and anal canal.
- •After endoluminal stenting of the trachea and after stenting of the digestive tract, and the participant did not resume normal diet or defecation.
- •Participants with biliary obstruction, unless local treatment for obstruction (e.g., endoscopic stent placement or percutaneous liver drainage) has been performed and TBIL has decreased to less than 1.5 × ULN.
- •Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh Class B or above.
- •Significant malnutrition, such as malnutrition requiring parenteral nutrition; except for those who have not used intravenous nutrition within 4 weeks before the first study treatment.
- •Uncontrolled active infection, including the following:
- •Infection requiring systemic antibiotic, antiviral, or antifungal therapy.
- •Human immunodeficiency virus (HIV) infection, or positive for HIV 1/2 Ab.
- •Acute or chronic active hepatitis B, defined as hepatitis B surface antigen positive (regardless of the results of antibodies to other antigens) or hepatitis B core antibody positive only (hepatitis B surface antibody negative and hepatitis B e antibody negative), and hepatitis B virus (HBV) DNA ≥ 1 × 10 4 copies/mL or ≥ 2000 IU/mL; or acute or chronic active hepatitis C, defined as hepatitis C virus (HCV) antibody positive and HCV RNA titer above the lower limit of detection.
- •Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year before the first dose of study drug.
- •Active syphilis infection or latent syphilis requiring treatment.
- •History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases.
- •History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation (except corneal transplantation).
- •Pregnant or lactating (may be considered if breastfeeding is discontinued) female participants, or participants planning to become pregnant.
- •Ineligible for any drug under study. Participants with contraindications to trastuzumab, pertuzumab monoclonal antibody, taxanes according to local prescribing information or IBI354 per the IBI354 Investigator's Brochure cannot be enrolled in the study.
- •Participant has known allergic or hypersensitivity reactions to the study treatments, camptothecin and its derivatives, other ADCs/anti-HER2 antibodies, and any excipients.
- •Complicated with other primary malignant tumors within 3 years or other malignant tumors with active or recurrent risk, excluding radically resected non-melanoma skin cancer (mainly including squamous cell carcinoma of skin and basal cell carcinoma of skin), radically resected carcinoma in situ, and papillary thyroid carcinoma.
- •Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up period after the end of study treatment in interventional studies.
- •Presence of substance abuse (excessive or inappropriate use of drugs, alcohol, or other harmful substances that may lead to physical, psychological, or social problems) or other acute or chronic diseases or laboratory abnormalities that, in the opinion of the investigator, may interfere with the participant's participation in the clinical study, increase the risk of study participation or drug administration, interfere with the interpretation of study results, or render the participant unsuitable for participation in the study in the judgment of the investigator.
- •The participant has a neurologic, psychiatric, or psychological illness or social condition that would interfere with trial compliance, substantially increase the risk of adverse events, or prevent the participant from providing written informed consent.
排除标准
- 未提供
研究组 & 干预措施
Group C
Active Comparator
THP
干预措施: Pertuzumab (Drug)
Group C
Active Comparator
THP
干预措施: Paclitaxel (Drug)
Group B
Experimental
IBI354
干预措施: IBI354 (Drug)
Group A
Experimental
IBI354 plus pertuzumab
干预措施: IBI354 (Drug)
Group A
Experimental
IBI354 plus pertuzumab
干预措施: Pertuzumab (Drug)
Group C
Active Comparator
THP
干预措施: Trastuzumab (Drug)
Group C
Active Comparator
THP
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
时间窗: Until progression or death, up to 54 months
Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
次要结局
- Progression Free Survival (PFS) by Investigator assessment(Until progression or death, up to 54 months)
- Overall Survival (OS)(Until death, up to 54 months)
- Objective Response Rate (ORR) by BICR and Investigator assessment(Until progression or death, up to 54 months)
- Duration of Response (DoR) by BICR and Investigator Assessment(Until progression or death, up to 54 months)
- Disease control rate (DCR) by BICR and Investigator assessment(Until progression or death, up to 54 months)
- Time to response (TTR) by BICR and Investigator assessment(Until progression or death, up to 54 months)
- Safety and tolerability of IBI354, alone or with pertuzumab(Until progression or death, up to 54 months)
- Immunogenicity of IBI354(Until progression or death, up to 54 months)
研究者
研究点 (1)
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