Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. A Multicenter Phase 1b/2a Trial in Colorectal Cancer, Non-small Cell Lung Cancer, and Soft Tissue Sarcoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 16
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.
详细描述
The therapeutic approach taken by this clinical trial may offer patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.
Patients giving written informed consent will undergo screening during the Pretreatment Period to determine eligibility for trial entry. The Pretreatment Period will include collection and recording of medical history, concomitant medications, baseline symptoms, previous therapies, and baseline assessments. The patient's baseline tumor burden will be recorded with radiological assessments, along with analyzing location and size of tumors to identify and characterize target tumor(s) that will be treated and/or followed during the clinical trial.
If confirmed eligible for the study, the patient will advance into the Treatment Period. During the Treatment Period, patients will receive a routine radiofrequency ablation (RFA), followed by an injection of investigational product (IP-001 for Injection) into the tumor. Patients can be treated every 6 weeks for up to 4 treatments with RFA + IP-001 for Injection.
A patient will move to the 6-month Follow-up Period when the patient has completed 4 treatment cycles or if the decision is made that no subsequent treatments will be administered. During the Follow-up Period, there will be a Follow-up Visit every 6 weeks for 5 visits, at disease progression, or prior to the start of a new antineoplastic treatment.
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
- •Stage 3 or Stage 4 CRC, NSCLC, or STS who have failed, are ineligible, refused, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy
- •Life expectancy of > 6 months. Only have lesions with the longest diameter of ≤ 5 cm.
- •Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm.
- •Measurable disease according to RECIST 1.
- •Age ≥ 18 years.
- •ECOG performance status 0-
- •Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
- •Adequate hematological function defined by white blood cell count ≥ 2.5 × 109/L with absolute neutrophil count ≥ 1.5 × 109/L, and hemoglobin ≥ 9 g/dL (transfusions allowed on study).
- •Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all patients, or for patients with documented metastatic disease to the liver and AST and ALT levels ≤ 5 × ULN. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN.
- •Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- •Men and women with childbearing potential agree to use effective contraception. Women of childbearing potential must have a negative pregnancy test (serum) before inclusion.
排除标准
- •Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.
- •Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease.
- •Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days prior to treatment.
- •Patients who have not recovered to common terminology criteria for adverse events (CTCAE) Grade ≤ 1 from all side effects of prior therapies except for residual toxicities.
- •Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers.
- •Concomitant treatment with systemic corticosteroids (10 mg prednisolone or equivalent) or other immunosuppressive therapy.
- •Anti-coagulation therapies which cannot be stopped 24 hours prior to trial treatment.
- •Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV).
- •Documented HIV positive.
- •Active Hepatitis C or Hepatitis B Viral infection.
研究组 & 干预措施
Colorectal Cancer (CRC)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
干预措施: 1.0% IP-001 for Injection (Drug)
Non-Small Cell Lung Cancer (NSCLC)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
干预措施: 1.0% IP-001 for Injection (Drug)
Soft Tissue Sarcoma (STS)
Radiofrequency ablation (RFA) followed by an intratumoral injection of IP-001.
干预措施: 1.0% IP-001 for Injection (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 12 weeks
The assessment of safety will be based on incidence of adverse events.
次要结局
- Efficacy: Disease control according to Immune Response Evaluation Criteria in Solid Tumors for immune-based treatment (iRECIST) (iDC)(Up to 12 weeks)
- Efficacy: Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC)(Up to 12 weeks)
- Efficacy: Duration of response according to iRECIST (iDOR)(Up to 12 weeks)
- Efficacy: Objective response according to iRECIST (iOR)(Up to 12 weeks)
- Efficacy: Progression-free survival according to iRECIST (iPFS)(Up to 12 weeks)
- Efficacy: Objective response according to RECIST 1.1 (OR)(Up to 12 weeks)
- Efficacy: Duration of response according to RECIST 1.1 (DOR)(Up to 12 weeks)
- Efficacy: Progression-free survival according to RECIST 1.1 (PFS)(Up to 12 weeks)
- Efficacy: Time to response according to iRECIST 1.1 (iTTR)(Up to 12 weeks)
- Efficacy: Time to response according to RECIST 1.1 (TTR)(Up to 12 weeks)
- Efficacy: Disease-free survival (DFS)(Up to 12 weeks)
- Efficacy: Overall survival (OS)(Up to 12 weeks)
- Efficacy: OR of the injected lesions according to RECIST 1.1(Up to 12 weeks)
- Efficacy: OR of the non-injected lesions according to RECIST 1.1(Up to 12 weeks)
- Efficacy: iOR of the injected lesions according to iRECIST(Up to 12 weeks)
- Efficacy: iOR of the non-injected lesions according to iRECIST(Up to 12 weeks)