EUCTR2022-000122-21-DE招募中1 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
uvalent, Inc.0 个研究点目标入组 470 人开始时间: 2022年11月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years
- •a. Phase 2 Cohort 2f only: Age =12 years and weighing >40 kg.(Patients age 12 to 17 will only be enrolled in countries and at sites
- •where regulations allow)
- •2. Disease criteria
- •a. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation detected by certified assay (i.e. CLIA in the US). The report from this test is required to be submitted for eligibility.
- •b. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC (excluding patients with documented transformation to non-NSCLC histology) with a documented ALK rearrangement detected by certified assay (i.e. CLIA in the US). The
- •report from this test is required to be submitted for eligibility.
- •c. Phase 2 Cohort 2f: Any other histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK
- •rearrangement or activating ALK mutation detected by certified assay, including but not limited to inflammatory myofibroblastic tumors,
- •esophageal squamous cell carcinoma, renal medullary carcinoma, renal cell carcinoma, breast cancer, colorectal cancer, ovarian cancer, papillary
- •thyroid carcinoma, cholangiocarcinoma, spitzoid tumors, neuroblastoma, and anaplastic thyroid cancer. The report from this test is required to be
- •submitted for eligibility
- •3. Prior anticancer treatment:
- •a. Phase 1: Patients with ALK fusion-positive NSCLC must have previously received =1 ALK TKI, one of which must be a 2nd or 3rd
- •generation TKI (ceritinib, alectinib, brigatinib, or lorlatinib). Patients with other solid tumors must have previously received =1 prior systemic
- •anticancer therapy or be those for whom no satisfactory standard therapy exists.
- •b. Phase 2 Cohort 2a: 1 prior 2nd generation ALK TKI (ceritinib, alectinib, or brigatinib) as the only prior ALK TKI; no prior investigational agents targeting ALK; = 2 prior lines of chemotherapy
- •and/or immunotherapy.
- •c. Phase 2 Cohort 2b: 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib or lorlatinib; no prior investigational agents targeting ALK; = 2 prior lines of chemotherapy and/or immunotherapy.
- •d. Phase 2 Cohort 2c: Lorlatinib as the only prior ALK TKI; no prior
- •investigational agents targeting ALK. Up to 1 prior line of chemotherapy
- •and/or immunotherapy received prior to lorlatinib is allowed.
- •e. Phase 2 Cohort 2d: Treatment naïve to ALK TKI therapy. Up to 1 prior line of chemotherapy and/or immunotherapy is allowed.
- •f. Phase 2 Cohort 2e: Any number of prior ALK TKIs, chemotherapy and/or immunotherapy; not eligible for other Phase 2 cohorts.
- •g. Phase 2 Cohort 2f: =1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists
- •4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease,
- •defined as =1 radiologically measurable target lesion according to
- •RECIST 1.1. Note: Patients with CNS-only disease are eligible, provided
- •that the disease is evaluable (Phase 1) or measurable (Phase 2) and
- •does not meet Exclusion Criterion #11
- •5. Pre-treatment tumor tissue (archived, if available, or a fresh biopsy)
- •submitted for central analysis. It is preferable that submitted tumor
- •tissue be obtained during or after the most recent disease progression.
- •If appropriate tissue is not available, and if biopsy is not considered safe
- •and medically feasible by the Investigator, th
排除标准
- •1. Patient's cancer has a known oncogenic driver alteration other than
- •ALK. Investigators should discuss enrollment with the Sponsor regarding
- •co-mutations.
- •2. Known allergy/hypersensitivity to excipients of NVL-655.
- •3. Major surgery within 4 weeks of the first dose of study drug. Minor
- •surgical procedures (e.g., port insertion) are permitted, but with
- •sufficient time for wound healing as deemed clinically appropriate.
- •4. Ongoing or recent anticancer therapy within the following timeframe
- •prior to first dose of study drug (NVL-655 may be started within limits
- •for prior TKI or chemotherapy if considered by the Investigator to be
- •safe and within the best interest of the patient, with prior approval from
- •the Sponsor):
- •a. TKI or other non-chemotherapy/non-immunotherapy anticancer
- •agents therapy not listed in exclusion criteria 4b or 4c below: <5 halflives
- •or <7 days, whichever is longer.
- •b. Chemotherapy, ADCs, or other antibodies <21 days
- •c. Immunotherapy or cellular therapy <28 days
- •5. Ongoing or recent radiation therapy within the following timeframe
- •prior to first dose of study drug:
- •a. Radiation therapy (except palliative radiation to relieve bone pain)
- •b. Palliative radiation to relieve bone pain <48 hours
- •c. Stereotactic or small field brain irradiation <7 days
- •d. Whole brain radiation <14 days
- •6. Prior high-dose chemotherapy requiring stem cell rescue.
- •7. Uncontrolled clinically relevant bacterial or fungal infection requiring
- •systemic therapy.
- •8. Has known active tuberculosis or active Hepatitis B or C. Active
- •Hepatitis B is defined as a known quantitative HBV DNA results greater
- •than the lower limits of detection of the assay. Active Hepatitis C is
- •defined by a known quantitative HCV RNA results greater than the lower
- •limits of detection of the assay.
- •9. Patient has a QTcF >450 msec (repeated demonstration on more
- •than one assessment). Patient has a history of prolonged QT syndrome
- •or Torsades de pointes.
- •10. Patients with clinically significant cardiovascular disease as follows:
- •a. Within 3 months of enrollment: cerebral vascular accident/stroke;
- •myocardial infarction; unstable angina; Grade = 3 atrial fibrillation.
- •b. History of congestive heart failure (New York Heart Association
- •Classification Class =II); second-degree or third-degree atrioventricular
- •block (unless paced) or any atrioventricular block with PR consistently
- •>220 msec; or ongoing cardiac dysrhythmias of NCI-CTCAE Grade =2
- •(excluding atrial fibrillation).
- •11. Patient has CNS metastases or a primary CNS tumor that is
- •associated with progressive neurological symptoms or requires
- •increasing doses of corticosteroids to control the CNS disease. If a
- •patient requires corticosteroids for management of CNS disease, the
- •dose must have been stable for the 2 weeks preceding C1D1.
- •Asymptomatic leptomeningeal carcinomatosis is allowed.
- •12. Symptomatic spinal cord compression.
- •13. Patients with moderate to severe cognitive impairment or
- 另有 8 项未显示
研究者
相似试验
招募中
2 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)2024-514266-39-00Nuvalent Inc.139
进行中（未招募）
1 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)EUCTR2022-000122-21-NLuvalent, Inc.470
进行中（未招募）
1 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)EUCTR2022-000122-21-ESuvalent, Inc.100
尚未招募
2 期
A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)Non Small Cell Lung Cancer NSCLC10027656Lung cancerNL-OMON56594uvalent, Inc.,8
招募中
不适用
Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancerbreast cancerJPRN-UMIN000030558Japanese Society for Sentinel Node Navigation Surgery240