NCT06413615尚未招募2 期
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients With Advanced/Metastatic Solid Tumors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fully understand and voluntarily participate in this study and sign informed consent.
- •Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose.
- •Eastern Cooperative Oncology Group performance status( PS) of 0 or
- •Life expectancy ≥ 3 months.
- •Histopathologically or cytologically confirmed advanced/unresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available:
- •Cohort A: Pathologically documented breast cancer that:
- •Is unresectable or metastatic.
- •Has a history of low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
- •For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.
- •Was never previously HER2-positive(IHC 3+ or IHC 2+/ISH+) on prior pathology testing or was historically HER2 IHC 0 only.
- •Cohort B: Pathologically documented endometrial cancer that:
- •Is unresectable or metastatic.
- •Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC).
- •Have had at least one prior line of platinum-based therapy (in any setting).
- •Was never previously received other ADC anti-tumor treatment.
- •Cohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer).
排除标准
- •A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.
- •Subjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months.
- •Subjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment).
- •Subjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy.
- •Adverse reactions from the previous anti-tumor treatment have not yet recovered (>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator).
- •Subjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:
- •a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
- •a medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
- •Subjects with a medical history of interstitial lung disease (ILD)/pneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening.
- •Subjects with any uncontrolled active infection within 1 week prior to first dose.
- •Subjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB
- •Subjects with a History of alcohol abuse or psychotropic/narcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons.
研究组 & 干预措施
HER2 Low Metastatic/Recurrent Breast Cancer
Experimental
Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
干预措施: FDA022-BB05 (Drug)
HER2 Expressing Metastatic/Recurrent Endometrial Cancer
Experimental
Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
干预措施: FDA022-BB05 (Drug)
HER2 Overexpressing/Mutant Metastatic/Recurrent Solid tumor
Experimental
Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W
干预措施: FDA022-BB05 (Drug)
结局指标
主要结局
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: up to 24 month
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
Objective Response Rate (ORR)
时间窗: up to 24 month
The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1
次要结局
- Disease control rate (DCR)(up to 24 month)
- Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum FDA022-BB05 Following First Dose(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Duration of response (DoR)(up to 24 month)
- Progression free survival (PFS)(up to 24 month)
- Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum FDA022-BB05 Following First Dose(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Number of participants who developed measurable anti-drug antibodies(up to 24 month)
- Overall survival (OS)(up to 24 month)
- Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum FDA022-BB05 Following First Dose(From cycle1 to Cycle10 (each cycle is 21 days. ))
- Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum FDA022-BB05 Following First Dose(From cycle1 to Cycle10 (each cycle is 21 days. ))
研究者
研究点 (1)
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