NCT05041972撤回2 期
A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Ambrx, Inc.
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)
详细描述
The study will enroll subjects with HER2-mutated or HER2-amplified/overexpressed locally advanced or metastatic solid tumor cancers whose prior standard of care therapies have failed. This basket trial will evaluate ARX788 across multiple cancer populations, as defined by HER2 genetic biomarkers
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and older
- •Life expectancy > 3 months
- •Eastern Cooperative Oncology Performance Status ≤ 1
- •HER2 status must be determined from a local Clinical Laboratory Improvement Amendments (CLIA) or equivalent-certified laboratory.
- •Cohort 1, Cohort 2, and Explanatory Cohort A: HER2 mutated subjects with pre-specified HER2 activating mutation. Subjects with HER2 mutations in NSCLC (Cohort 1), breast cancer (Cohort 2), and other solid tumors (Cohort A) who have not received prior HER2 antibody drug conjugate (ADC) treatment are eligible.
- •Cohort 3: Subjects with HER2 amplifications in biliary tract cancers (BTC) who have not received prior HER2 ADC treatment are eligible.
- •Cohort 4: Subjects with HER2 amplifications in colorectal cancer (CRC), ovarian, endometrial, NSCLC and other solid tumors who have not received prior HER2 ADC treatment are eligible.
- •Cohort 5 HER2 mutation or HER2 amplification: subjects with HER2 mutated or amplified tumors and have been previously treated with HER2 ADC are eligible.
- •Subjects who are resistant or refractory to previous standard care of treatment.
- •Subjects with stable brain metastases.
- •Adequate organ functions.
排除标准
- •Any subject who meets any of the following criteria is excluded from the study:
- •For Cohort 4: breast and gastric/GEJ cancer are excluded.
- •Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months.
- •History of ocular events, any current ongoing active ocular infections, or any chronic corneal disease unless approved by Medical Monitor.
- •Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX
- •Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX
- •Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.
- •There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
研究组 & 干预措施
Cohort 1: HER2 Mutated Non-Small Cell Lung Cancer (NSCLC)
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
Cohort 2: HER2 Mutation Breast Cancer
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
Exploratory Cohort A: Other HER2-Mutated tumors
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
Cohort 3: HER2 Amplification Biliary Tract Cancer (BTC)
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
Cohort 4 HER2 Amplification Colorectal (CRC), Ovarian Endometrial, NSCLC, and other solid tumors
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
Cohort 5: HER2 Mutation or HER2 Amplification Solid Tumors
Experimental
Intervention: Drug: ARX788
干预措施: ARX788 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At the end of every 2 cycles (each cycle is 21 days)
The confirmed objective response rate (ORR) of ARX788 by blinded independent central review (BICR) based on RECIST 1.1 in Cohorts 1-5. The ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable subjects
次要结局
- Trough concentration (Ctrough) for ARX788, total antibody, and metabolites(Cycle 1 and Cycle 3)
- Progression Free Survival (PFS)(2 years)
- Incidence of anti-drug antibodies (ADAs)(Predose at every cycle (each cycle is 21 days))
- Disease Control Rate (DCR)(2 years)
- Overall Survival (OS)(2 years)
- Best Overall Response (BOR)(At the end of every 2 cycles (each cycle is 21 days))
- Time to Response (TTR)(At the end of every 2 cycles (each cycle is 21 days))
- Duration of Response(1 year)
- Maximum serum concentration (Cmax) for ARX788, total antibody, and metabolites(Cycle 1 and Cycle 3)
研究者
研究点 (2)
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