EUCTR2022-000122-21-NL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 470 人开始时间: 2023年3月9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
- 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 Investigato
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 half-lives 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) <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 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 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, or localized and presumed cured breast or prostate cancer. Patients on long-term anti-hormonal therapy for a prior malignancy are allowed if the malig
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