NCT03190824Unknown2 期
Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients With Unresectable Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions
研究概览
简要总结
Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP 301 in patients with unresectable/unresected metastatic melanoma. This proof of concept study will be undertaken in male and female patients with unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal melanoma may be enrolled after consultation with the Medical Monitor.
详细描述
Primary Objective:
The primary objective of this study is to evaluate the overall tumor sites response (objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions up to and including Week 24 in patients with unresectable/unresected Stage III and IV melanoma. The ORR is defined as the rate of complete response (CR) and partial response (PR) based on the modified immune-related response criteria (irRC) 1.0. The modification is to allow the identification of up to 10 cutaneous, subcutaneous, and/or lymph node tumor lesions and identify the lesions as target and nontarget lesions.
Secondary Objectives:
- To evaluate the ORR up to and including Week 24 in injected target lesions based on the modified irRC 1.0 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- To evaluate the ORR up to and including Week 24 in noninjected target lesions based on modified irRC 1.0 and RECIST 1.1
- To evaluate the ORR in both injected and noninjected target lesions at Week 12 based on the modified irRC 1.0 and RECIST 1.1
- To evaluate duration of response and time to response
- To evaluate progression free survival (PFS) at Week 24 and Week 48
- To evaluate overall survival (OS) at Week 24 and Week 48
- To evaluate the safety of OBP 301
Exploratory Objective (optional):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed malignant melanoma at Screening that is unresectable/unresected Stage IIIB, IIIC, IIID or IV. Patients with unresectable mucosal melanoma may be enrolled after consultation with the Medical Monitor.
- •Patients must have received and failed or refused available therapy for unresectable/unresected Stage III or IV melanoma.
- •Patients must be ≥ 18 years of age.
- •At least 2 cutaneous, subcutaneous and/or lymph node target lesions that are greater or equal to 1 cm in the longest diameter. One of the cutaneous, subcutaneous and/or lymph node target lesions should be designated at Screening as a noninjected target lesion. Willing to have biopsy specimens taken at Screening and at Week
- •Life expectancy of ≥ 6 months from the first OBP-301 treatment.
- •Karnofsky Performance Status Scale (KPS) score of ≥
- •Adequate organ function, hematologic status, coagulation status, kidney function, and liver function as follows:
- •Absolute neutrophils > 1,500/µL
- •Hemoglobin > 9 g/dL, without transfusion or hematopoietic growth factor
- •Platelets > 100,000/µL. Patients with ≤ 100,000 platelet count may be allowed into the study on a case-by-case basis after consultation with the Medical Monitor.
- •Serum creatinine < 2 × upper limit of normal (ULN)
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × ULN except for patients with known liver metastases, in which case aspartate transaminase or alanine transaminase may be ≤ 5.0 × ULN
- •Total bilirubin < 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome)
- •Serum lactate dehydrogenase (LDH) levels < 1.5 × ULN
- •Understand the study requirements and the treatment procedures, and is willing to comply with all specified follow-up evaluations, and provides written informed consent before any study-specific tests or procedures are performed.
- •Patients of reproductive potential must use effective contraception for the duration of the study and for 3 months (90 days) after the last administered injection of OBP-
- •Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device.
排除标准
- •Patients who have had administration of chemotherapy, target therapy, and/or immunotherapy within the last 4 weeks before the first OBP-301 administration.
- •Patients who have received other investigational medication within the last 4 weeks or a period of its 5 half-lives (whichever is shorter) before the first OBP-301 administration.
- •Patients who have had radiotherapy within the last 4 weeks before the first OBP-301 administration.
- •Effects of any other prior therapies not reverted to ≤ Grade 1 (or ≤ Grade 2 for alopecia and peripheral neuropathy).
- •Patients who have any liver metastases or visceral metastasis of ≥ 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration.
- •Patients with clinically active brain metastases. However, patients with previously currently stable brain metastases on medication (i.e., steroids and/or anti-seizure medications) may be enrolled after consultation with the Medical Monitor.
- •Patients known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- •Patients diagnosed with additional malignancy within 3 years before the first OBP-301 administration with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
- •Patients requiring chronic systemic immunosuppressive medication including pharmacologic dose of glucocorticoids or cyclosporine should be evaluated by the Medical Monitor for enrollment eligibility.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/psychological incompetence, whereby in the opinion of the Investigator the patient is assessed as being unable to provide information, consent, or comply with the study requirements and procedures.
- •Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-
- •A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.
研究组 & 干预措施
OBP-301
Experimental
Eligible patients with unresectable Stage III and IV melanoma will receive up to 13 treatments of OBP 301 at a concentration of 1 × 1012 virus particles (VP)/mL for 24 weeks.
干预措施: OBP-301 (Drug)
结局指标
主要结局
Evaluate objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions
时间窗: up to Week 24
Objective response rate \[ORR\]) to OBP-301 in both injected and noninjected lesions in patients with unresectable/unresected Stage III and IV melanoma. The modification is to allow the identification of up to 10 cutaneous, subcutaneous, and/or lymph node tumor lesions and identify the lesions as target and nontarget lesions.
次要结局
- Overall Response Rate at weeks 6, 12, 18, and 24 in the combined and individual injected lesions(Week 24 and Week 48)
- Best Overall Response Rate at weeks 6, 12, 18, and 24 in injected and noninjected lesions(Week 24 and Week 48)
- Time to Treatment Response from start date to end date(Week 24 and Week 48)
- Duration of response of injected and noninjected lesions(Week 24 and Week 48)
- Safety of OBP-301 as assessed by changes in clinical laboratory parameters(Through study completion)
- Overall Survival at weeks 24 and 48(Week 24 and Week 48)
- Safety of OBP-301 as assessed by incidence of AEs and SAEs(Through study completion)
- Progression Free Survival at weeks 24 and 48(Week 24 and Week 48)
研究者
研究点 (1)
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