NCT03573544终止1 期
A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Clinical Benefit Rate (CR, PR, SD) (%)
研究概览
简要总结
The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients must meet all of the following criteria in order to be included in the study:
- •Male or female patients, 18 years of age or older at the time of consent.
- •Provide written informed consent prior to performing any study-related procedure.
- •Histologically or cytologically confirmed patients with advanced or metastatic solid tumors for both Dose Escalation and Expansion cohort.
- •Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy.
- •Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function defined as:
- •Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
- •Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in presence of liver metastases
- •Serum bilirubin ≤1.5 × ULN
- •Creatinine clearance >30 mL/minute using Cockcroft Gault equation
- •Hematologic:
- •Absolute neutrophil count ≥1000/µL
- •Platelets ≥75,000/µL
- •Hemoglobin ≥8 g/dL
- •Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
- •Females of childbearing potential must have negative urine or serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.
- •Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
- •Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
- •Cannot be breast feeding.
- •Patients in Part B (Cohort expansion); must have a qualifying, documented Globo H H-score in sponsor-selected tumor types to be enrolled in the respective cohort:
- •Cohort 1: Pancreatic cancer
- •Cohort 2: Esophageal cancer
- •Cohort 3: Gastric cancer
- •Cohort 4: Colorectal cancer
- •Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4)
排除标准
- •Patients meeting any of the following criteria are ineligible to participate in this study:
- •Less than 3 weeks, from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks from biological therapies, whichever is shorter, prior to the first dose of OBI-
- •Has undergone a major surgical procedure (as defined by the investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-
- •Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, topical, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not be excluded from the study.
- •Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of OBI
- •Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic therapy, including known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus.
- •Patients with a history of solid organ transplant.
- •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03), except for alopecia and laboratory values listed in the inclusion criteria.
- •Receipt of any prior therapy targeting Globo H.
- •Known hypersensitivity to OBI 888 or its excipients.
- •Has known, untreated central nervous system metastases and/or leptomeningeal metastases.
- •Any medical co morbidity or psychiatric illness that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
- •Is receiving any concurrent prohibited medication
研究组 & 干预措施
OBI-888 Escalation Phase
Experimental
Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).
干预措施: OBI-888 (Drug)
OBI-888 Escalation Phase
Experimental
Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).
干预措施: Globo H IHC Assay (Device)
OBI-888 Expansion Phase
Experimental
Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
干预措施: OBI-888 (Drug)
OBI-888 Expansion Phase
Experimental
Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.
干预措施: Globo H IHC Assay (Device)
结局指标
主要结局
Clinical Benefit Rate (CR, PR, SD) (%)
时间窗: Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.
Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.
次要结局
未报告次要终点
研究者
研究点 (9)
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