NCT04653038终止1 期
An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 13
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.
详细描述
The study is conducted in two parts for both Cohort 1 and Cohort 2. Part I: Safety evaluation and efficacy exploration for MGD013. Part II: Efficacy expansion based on results from Part I to further evaluate the efficacy effect of MGD013.
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
- •Voluntary and able to provide signed informed consent form
- •Male or female aged ≥ 18 years
- •Patient can comply with protocol requirements as assessed by the investigator
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, or 1
- •Histologically confirmed unresectable recurrent or metastatic melanoma:
- •Cohort 1: The pathological type is cutaneous or acral lentiginous, or unknown origin. Progressive or recurrent disease on at least one prior line of systemic therapies. In addition, prior systemic therapies must include one line of anti-PD-(L)1 and/or anti-CTLA-4 immune checkpoint inhibitors. Patients with BRAF-mutated or KIT-mutated/amplified melanoma, and prior treatment with vemurafenib or imatinib is not mandatory;
- •Cohort 2: Histologically confirmed pathological type is acral lentiginous or mucosal. No prior systemic therapy for recurrent or metastatic disease.
- •Patients with at least one measurable lesion according to irRECIST; assessed by investigator per irRECIST criteria to establish a baseline tumor assessment, and should be performed within 28 days prior to the first dose.
排除标准
- •The pathological type of patient is:
- •Cohort 1: Mucosal melanoma; uveal melanoma;
- •Cohort 2: Cutaneous melanoma; uveal melanoma; melanoma of unknown origin; known BRAF mutation or KIT mutation/amplification.
- •Central nervous system metastases with clinical symptoms. Patients with prior central nervous system metastases who have received local therapy, have stable disease for ≥ 4 weeks, and meet the following criteria can be enrolled:
- •No treatment for central nervous system metastases during the screening period (e.g., surgery, radiotherapy, mannitol, corticosteroid therapy-prednisolone > 10 mg per day or equivalent dose)
- •No progression of central nervous system lesions on MRI or CT within 14 days prior to start of study treatment
- •No meningeal metastasis or notochord compression
- •Subjects with a history of symptomatic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function or may interfere with the detection and treatment of suspected drug-related pulmonary adverse reactions;
- •Prior treatment with any antibody/drug targeting the regulation of T cell function (immune checkpoint) (e.g., anti-LAG-3, anti-0X-40, anti-CD137, anti-TIM-3, anti-TIGIT, IDO)
- •Patients who have previously received immune checkpoint inhibitors (e.g., anti-PD-(L)1, anti-CTLA-4 antibody) are not included if they experience any of the following immune checkpoint-related adverse events, regardless of recovery:
- •≥ Grade 3 ocular adverse events
- •Grade 4 liver function abnormalities
- •Grade ≥ 3 neurologic adverse reactions
- •≥ Grade 3 colitis
- •≥ Grade 3 renal adverse reactions
- •≥ Grade 3 pneumonitis
研究组 & 干预措施
Unresectable, recurrent or metastatic melanoma
Experimental
Cohort1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy
干预措施: MGD013 (Drug)
Untreated mucosal or acral lentiginous melanoma
Experimental
Cohort2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma
干预措施: MGD013 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Approximately 12 months after dosed
Objective Response Rate (ORR) is defined as the proportion of patients with a best response of CR or PR in enrolled patients, which is assessed by Independent Review Committee (IRC) per RECIST v1.1
次要结局
- Overall Survival (OS)(Approximately 24 months)
- Objective Response Rate (ORR)(Approximately 12 months after dosed)
- Survival Rate(Approximately 12 months after dosed)
- Incidence of Adverse Events(Approximately 24 months)
- Progression-free Survival (PFS)(Approximately 12 months after dosed)
- Trough Serum Concentration (Ctrough)(Approximately 3 months)
- Disease Control Rate (DCR)(Approximately 12 months after dosed)
- Duration of Response (DoR)(Approximately 12 months after dosed)
- Incidence of Abnormal Laboratory value(Approximately 24 months)
- Incidence of Treatment-Emergent Adverse Events(Approximately 24 months.)
- Maximum Serum Concentration (Cmax)(Approximately 3 months.)
- Immunogenicity of MGD013(Approximately 6 months after dosed)
研究者
研究点 (13)
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