jRCT2031250006招募中不适用
A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (OrigAMI-4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 247
- 主要终点
- Objective Response Rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies. Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (a) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (b) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (c) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (c) Participants must provide local testing results of PD-L1 status
- •Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.
- •Participants in Cohort 3A must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1
- •Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormone replacement)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test.
- •Participants should have: a) Hemoglobin >=9 grams per deciliter (g/dL); b) Neutrophils >=1.5 x 10^3/mcg; c) Platelets >=100 x 10^3/mcg
排除标准
- •Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- •Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
- •Participant with a history of clinically significant cardiovascular disease
- •Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days
- •Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
结局指标
主要结局
Objective Response Rate
时间窗: 2 years and 2 months
ORR is defined as the proportion of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1.
Number of Participants With Dose-limiting Toxicities (DLT)
时间窗: Up to 21 days
Number of participants with DLTs will be reported. A DLT is defined as any of the following: treatment delay of greater than (>) 28 days due to unresolved toxicity, non-hematologic toxicity of Grade 3 or higher, hematologic toxicity of Grade 4 neutropenia persisting for >7 days or Grade 3 or higher thrombocytopenia with clinically significant bleeding or neutropenic fever of any grade, and liver enzyme elevation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
时间窗: 2 years and 1 month
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.
次要结局
- Duration of Response (DoR)(2 years and 2 months)
- Clinical Benefit Rate (CBR)(2 years and 2 months)
- Progression-free Survival (PFS)(2 years and 2 months)
- Overall Survival (OS)(2 years and 2 months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity(2 years and 1 month)
- Maximum Observed Serum Concentration (Cmax) of Amivantamab(Predose up to 168 hours post dose on Day 1)
- Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab(Predose up to 168 hours post dose on Day 1)
- Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab(Predose up to 168 hours post dose on Day 1)
- Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab(Predose up to 168 hours post dose on Day 1)
- Trough Serum Concentration (Ctrough) of Amivantamab(Predose up to 168 hours post dose on Day 1)
- Accumulation Ratio (R) of Amivantamab(Predose up to 168 hours post dose on Day 1)
研究者
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