NL-OMON53810招募中2 期
A Phase 1/2 Study of the Highly Selective ROS1 Inhibitor NVL-520 in Patients with Advanced NSCLC and Other Solid Tumors (ARROS-1) - NVL-520-01
uvalent, Inc.0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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 64（—）
入选标准
- •1. Age >=18 years a. Phase 2 Cohort 2e only: Age >=12 years and weighing > 40 kg.
- •(Patients ages 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
- •documented ROS1 rearrangement, determined by testing in a Clinical Laboratory
- •Improvement Amendments (CLIA) laboratory in the US or equivalently accredited
- •diagnostic lab outside the United States (US) and using a local diagnostic test
- •or a commercial test or by a regulatory agency approved test, such as
- •fluorescence in situ hybridization (FISH) or next generation sequencing (NGS)
- •or reverse transcription polymerase chain reaction (RT-PCR). The report from
- •this test is required to be submitted for eligibility. b. Cohorts 2a, 2b, 2c
- •and 2d: Histologically or cytologically confirmed locally advanced or
- •metastatic NSCLC with ROS1 rearrangement as determined by testing in a CLIA or
- •equivalently accredited diagnostic lab using a local diagnostic test or a
- •commercial test or by a regulatory agency approved test, such as FISH or NGS or
- •RT-PCR. The report from this test is required to be submitted for eligibility.
- •c. Cohort 2e: Histologically or cytologically confirmed locally advanced or
- •metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2d) with
- •ROS1 rearrangement as determined by testing in a CLIA or equivalently
- •accredited diagnostic lab using a local diagnostic test or a commercial test or
- •by a regulatory agency approved test, such as FISH or NGS or RT-PCR. The report
- •from this test is required to be submitted for eligibility. 3. Prior anticancer
- •treatment a. Phase 1: Patients with ROS1 fusion-positive NSCLC must have
- •previously received at least 1 prior ROS1 TKI, while those with other
- •ROS1-positive solid tumors must have progressed on any prior therapy (includes,
- •but is not limited to, patients whohave progressed on prior ROS1 TKIs). Any
- •number of prior platinum-based chemotherapies with or without immunotherapy is
- •allowed. b. Cohort 2a: Must be nai*ve to TKI therapy and up to one prior
- •platinum-based chemotherapy (with or without immunotherapy). c. Cohort 2b: Must
- •have received 1 prior ROS1 TKI therapy (either crizotinib or entrectinib) and
- •no prior platinum-based chemotherapy or immunotherapy. d. Cohort 2c: Must have
- •received 1 prior ROS1 TKI therapy (either crizotinib or entrectinib) and 1
- •prior platinum-based chemotherapy (with or without immunotherapy). e. Cohort
- •2d: Must have received at least 2 prior ROS1 TKI therapies and up to 1 prior
- •platinum-based chemotherapy (with or without immunotherapy). f. Cohort 2e: Must
- •have progressed on any prior therapy (includes, but is not limited to, patients
- •who have progressed on prior ROS1 TKIs). 4. Phase 1: Must have evaluable
- •disease (target or nontarget) according to RECIST 1.1 (Eisenhauer et al, 2009;
- •Appendix 3). 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
排除标准
- •1. Patient*s cancer has a known oncogenic driver alteration other than ROS1.
- •For example, NSCLC with a targetable mutation in EGFR, ALK, MET, RET, or BRAF;
- •colorectal with an oncogenic KRAS, NRAS, or BRAF mutation. Investigators should
- •discuss enrollment with the Sponsor regarding co-mutations. 2. Known
- •allergy/hypersensitivity to excipients of NVL-520. 3. Major surgery within 4
- •weeks of first dose of study drug. Minor surgical procedures (eg, 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-520 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 anticancer therapy not listed below in
- •exclusion criteria 4b or 4c: <5 half-lives or <7 days, whichever is longer b.
- •Chemotherapy, antibody-drug conjugates (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 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
研究者
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