NCT04084366终止1 期
A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced 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
- 44
- 试验地点
- 4
- 主要终点
- Objective Response Rate (ORR) (CR+PR)
研究概览
简要总结
The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced 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
- •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 solid tumors.
- •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. In the latter case, the informed consent must state the effective therapies the patient is declining.
- •Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function defined as:
- •a. Hepatic:
- •i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
- •ii. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
- •iii.Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)
- •i. Creatinine clearance >50 mL/minute using Cockcroft Gault equation
- •c. Hematologic:
- •i. Absolute neutrophil count ≥1,500/µL
- •ii. Platelets ≥100,000/µL
- •iii. Hemoglobin ≥8 g/dL
- •Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including a pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
- •Females of childbearing potential must have negative 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.
- •Patient 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 with human immunodeficiency virus (HIV) infection are eligible if CD4+ T cell counts ≥ 350 cells/uL; patients on antiretroviral therapy (ART) should be on an established dose for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- •Patients with serological evidence of chronic hepatitis B virus (HBV) infection are eligible if they have an HBV viral load below the limit of quantification with or without concurrent viral suppressive therapy.
- •Patients with a history of hepatitis C virus (HCV) infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
- •Patients in Part B (Cohort-Expansion) must have documented Globo H H score of at least 100 from a qualified laboratory IHC assay in one of the 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
- •Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, 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
- •Sensory or motor neuropathy of Grade 2 or greater.
- •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 NCI CTCAE version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
- •Receipt of any prior therapy targeting Globo H.
- •Known hypersensitivity to OBI 999 or its excipients.
- •Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]) during the screening period.
- •Has significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina)
- •Any medical co morbidity 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-999 Escalation phase
Experimental
Part A: Five cohorts at escalating dose levels 0.4, 0.8, 1.2, 1.6 and 2.0 mg/kg (capping calculations at a maximum at 100 kg) of OBI-999 liquid form via IV infusion to establish maximum tolerated dose (MTD) and Recommended phase 2 dose (RP2D).
干预措施: OBI-999 (Drug)
OBI-999 Expansion Phase
Experimental
Part B: Five cohorts of patients at RP2D of OBI-999 liquid form, as determined from Part A, via IV infusion.
干预措施: OBI-999 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) (CR+PR)
时间窗: Every 6 weeks (±7 days) for first 3 months, then every 9 weeks (±7 days) until discontinuation of study treatment, disease progression, death, or initiation of further cancer therapy, or for up to 35 cycles (approximately 2 years.), whichever occurs first
Assessment of OBI-999 clinical benefit rate for dose escalation and cohort expansion phases of the OBI 999-001 study.
次要结局
未报告次要终点
研究者
研究点 (4)
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