EUCTR2022-000122-21-ES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)
uvalent, Inc.0 个研究点目标入组 100 人开始时间: 2022年5月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age > or =18 years
- •a. Phase 2 Cohort 2d only: Age > or =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 2a, 2b, and 2c: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement detected by certified assay. The report from this test is required to be submitted for eligibility.
- •c. Phase 2 Cohort 2d: 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 anaplastic large cell lymphoma, inflammatory myofibroblastic tumors, diffuse large B-cell lymphoma, esophageal squamous cell carcinoma, renal medullary carcinoma, renal cell carcinoma, breast cancer, colorectal cancer, ovarian cancer, papillary thyroid carcinoma, cholangiocarcinoma, spitzoid tumors, neuroblastoma, anaplastic thyroid cancer, and patients with NSCLC not eligible for Cohorts 2a-c. 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 > or =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 > or =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
- •c. Phase 2 Cohort 2b: 2-3 prior 1st or 2nd generation ALK TKIs (crizotinib, ceritinib, alectinib, or brigatinib)
- •d. Phase 2 Cohort 2c: 2-3 prior ALK TKIs, with lorlatinib received in the 2nd or 3rd line of therapy
- •e. Phase 2 Cohort 2d: > or =1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists
- •f. All patients except Phase 2 Cohort 2d: < or = 2 prior lines of chemotherapy and/or immunotherapy in the locally advanced or metastatic setting. Patients who have received >2 prior lines of chemotherapy and/or immunotherapy in the locally advanced or metastatic setting may be enrolled in Phase 2 Cohort 2d.
- •g. Phase 2 Cohorts 2a, 2b and 2c: No prior investigational agents targeting ALK. Patients who previously received investigational agents targeting ALK may be enrolled in Phase 1 and Phase 2 Cohort 2d.
- •4. Phase 1: Must have evaluable disease according to RECIST 1.1
- •Phase 2: Must have measurable disease, defined as > or =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, the patient may be approved for enrollment after consultation
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 <5 half-lives or <7 days, whichever is longer.
- •b.Chemotherapy <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) <14 days
- •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 positive HBsAg result and known quantitative HBV DNA results greater than the lower limits of detection of the assay. Active Hepatitis C is defined by a known positive Hep C Ab result and 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; uncontrolled atrial fibrillation of any grade.
- •b.History of congestive heart failure (New York Heart Association Classification Class > or = 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 > or =2.
- •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 psychiatric disturbances that would compromise the patient’s ability to comply with study requirements, in the Investigator’s opinion.
- •14.Evidence of active malignancy (other than current ALK-positive solid malignancy) requiring systemic therapy within the prior 2 years. Exceptions: nonmelanoma skin cancer, in situ melanoma, in situ cervical cancer, papillary thyroid cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer. Patients on long-term anti-hormonal therapy for a prior malignancy are allowed if the
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