NL-OMON56594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) - ALKOVE-1
uvalent, Inc.,0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
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
- 年龄范围
- 16 至 99（—）
入选标准
- •1. Age >=18 years a. Phase 2 Cohort 2d 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 2a, 2b, and 2c: 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 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 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,
- •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 >=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 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: >=1 prior systemic
- •anticancer therapy, or for whom no satisfactory standard therapy exists f. All
- •patients except Phase 2 Cohort 2d: <= 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 (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 diseas
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
- •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 >=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.
- •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, <br
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