NCT03052205已完成1 期
A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors (ILLUMINATE-101)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 12
- 主要终点
- Melanoma Expansion Cohort: Number of patients with treatment-related adverse events as assessed by CTCAE
研究概览
简要总结
This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.
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
- •Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
- •Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies.
- •a. Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L)1 inhibitor.
- •a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.
- •b) Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.
- •Patients must be 18 years of age or older.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Patients must meet the following laboratory criteria:
- •Absolute neutrophil count ANC ≥1.5 x 109/L (≥1500/mm3)
- •Platelet count ≥75 x 109/L (≥75,000/mm3)
- •Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
- •Serum creatinine ≤1.5 x ULN or calculated 24-hour creatinine clearance ≥60 mL/minute
- •Aspartate aminotransferase (AST) ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
- •Total bilirubin ≤1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 μmol/L)
- •Women of childbearing potential and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 4 weeks after the last dose of study drug.
- •Patients must be willing and able to provide signed informed consent and comply with the study protocol.
排除标准
- •Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility.
- •Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
- •Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
- •Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.
- •Patients with active autoimmune disease requiring disease-modifying therapy.
- •Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).
- •Patients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
- •Patients with active infections requiring systemic treatment.
- •Patients who are known to be hepatitis B surface antigen positive.
- •Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
- •Women who are pregnant or breastfeeding.
- •Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <10 mg/day of prednisone (or equivalent).
- •Patients with impaired cardiac function or clinically significant cardiac disease:
- •New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
- •Unstable angina pectoris ≤6 months prior to study participation
- •Acute myocardial infarction ≤6 months prior to study participation
- •Other clinically significant heart disease (i.e., Grade ≥3 hypertension, history of labile hypertension, or poor compliance with an anti-hypertensive regimen)
- •Have not recovered (to baseline or Grade ≤1) from toxicity associated with prior treatment.
研究组 & 干预措施
IMO-2125 at escalating dose levels
Experimental
IMO-2125 at escalating dose levels by intratumoral injection
干预措施: IMO-2125 (Drug)
结局指标
主要结局
Melanoma Expansion Cohort: Number of patients with treatment-related adverse events as assessed by CTCAE
时间窗: 51 weeks of treatment
Melanoma Expansion Cohort: Objective response rate
时间窗: Assessed every 9 weeks for duration of study participation, which is estimated to be 51 weeks
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Objective response rate
时间窗: Assessed every 6 weeks for duration of study participation, which is estimated to be 51 weeks
Dose Evaluation Cohorts, non-Melanoma Dose Evaluation Cohorts: Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D).
时间窗: 51 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (12)
Loading locations...
相似试验
终止
1 期
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid TumorsMetastatic CancerSoft Tissue SarcomaTriple Negative Breast CancerNon Small Cell Lung CancerMelanomaMerkel Cell CarcinomaNCT04725331Transgene31
尚未招募
1 期
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 MutationBRAF V600 MutationNonsmall Cell Lung CancerCancerColorectal CancerMelanomaThyroid CancerNCT05275374Xynomic Pharmaceuticals, Inc.221
已完成
1 期
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV MelanomaMelanomaNCT01672450University of Utah12
已完成
2 期
Intratumoral Administration of L19IL2/L19TNFMalignant Melanoma, SkinNCT02076633Philogen S.p.A.21
终止
1 期
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung CancerNon Small Cell Lung CancerNon Small Cell Lung Cancer Stage IIIBNon-small Cell Lung Cancer Stage IVSquamous Non-small-cell Lung CancerLarge Cell Carcinoma LungAdenocarcinoma LungNCT04432207Imugene Limited24