ISRCTN57038506进行中（未招募）1 期
A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects with Non-Small Cell Lung Cancer – KisMET-01
Mythic Therapeutics0 个研究点目标入组 200 人开始时间: 2024年4月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
- •1. Part 1:
- •a. Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC and have received available standard of care therapy.
- •b. There is no limit on the number of prior therapies that can have been received.
- •2. Part 2 (Cohorts A-E):
- •a. Known to not have an actionable EGFR mutation. Subjects with or without other driver mutations are permitted to enroll.
- •b. Must have received available standard of care therapy.
- •c. Must have progressed on at least 1 line of prior therapy in the locally advanced/metastatic setting. Note: multiple lines of tyrosine kinase inhibitor (TKI) for the same actionable mutation count as 1 line of therapy. Maintenance therapy is not considered a separate line of therapy. Adjuvant and neoadjuvant therapies count as 1 line of therapy if given within 6 months before study entry.
- •d. Subjects without any actionable gene alteration: must have progressed on (or be considered ineligible for), or be intolerant to, platinum-based chemotherapy and immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy).
- •e. Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint inhibitor therapy is not standard of care (e.g., anaplastic lymphoma
- •kinase [ALK] translocation): must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alterations and
- •platinum-based chemotherapy.
- •f. Subjects with actionable gene alterations (other than EGFR) for which immune checkpoint inhibitor is standard of care: must have progressed on (or be considered ineligible for), or be intolerant to, anticancer therapy targeting driver gene alternation and platinum-based chemotherapy, and also progressed on (or be considered ineligible for) or be intolerant to immune checkpoint inhibitor (as monotherapy or in combination with platinum-based chemotherapy).
- •3. Part 2:
- •a. Cohort A:
- •i. Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC.
- •ii. Tumor sample with high cMET expression by IHC (3+ with tumor cell positivity of =50%) confirmed by central laboratory testing.
- •b. Cohort B:
- •i. Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic non-squamous NSCLC.
- •ii. Tumor sample with intermediate cMET expression by IHC (3+ with tumor cell positivity of = 25% - <50%) confirmed by central laboratory testing.
- •c. Cohort C:
- •i. Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic squamous NSCLC.
- •ii. Tumor sample with cMET overexpression by IHC (2+ with tumor cell positivity of = 25%) confirmed by central laboratory testing.
- •d. Cohort D:
- •i. Have histologically or cytologically confirmed locally advanced, recurrent (and not a candidate for curative therapy), or metastatic NSCLC.
- •ii. Tumor sample that does not meet cMET IHC entry criteria for Cohorts A and B (for subjects with non-squamous NSCLC) and C (for subjects with squamous
- •NSCLC) based on central laboratory testing.
- •iii. Known MET amplification or exon 14 skipping mutations, respectively, performed in a CLIA-certified laboratory in the US or equivalently accredited diagnostic labo
排除标准
- •Subjects who meet any of the following exclusion criteria will be excluded from this study:
- •1. NSCLC with adeno-squamous histology (for Cohorts A, B, and C only; subjects with NSCLC with adeno-squamous histology are allowed in Cohorts D and E).
- •2. Radiation to the lung within 6 weeks prior to screening. For all other sites (except lung and brain), therapeutic or palliative radiation within 2 weeks of the first dose of study drug. Must have recovered from all radiation-related toxicity.
- •3. Major surgery within 28 days before first dose of study drug administration.
- •4. Systemic anticancer therapy including investigational drugs, within the lesser of 28 days or 5 half-lives of the prior therapy before starting study drug (14 days or 5 half-lives for small molecule targeted therapy).
- •Concurrent use of hormonal therapy for breast cancer or prostate cancer is permitted.
- •5. Previously received cMET-targeted antibody or ADC, bicycle, or small peptide therapies targeting cMET.
- •Note: For Cohort E: Subjects will have previously received and progressed on either cMET-targeted ADC or antibody; however, they must not have been intolerant to the
- •cMET-targeted ADC or antibody therapy.
- •6. Use of any concomitant or prohibited therapies outlined in Section 7.6.
- •7. Untreated, uncontrolled CNS metastases. Subjects with CNS metastases who have had surgical resection or have received radiation therapy to all known sites of CNS disease ending at least 4 weeks prior to first dose of study drug are eligible if:
- •a. There is no evidence of disease progression after at least 2 weeks after the end of definitive therapy; and
- •b. The subject is neurologically stable and either off or on a non-increasing dose (in the past 2 weeks) of systemic steroids.
- •8. Known history of human immunodeficiency virus (HIV) infection.
- •9. Untreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •a. HBV: Subjects with serological evidence of chronic HBV infection should have an HBV viral load below the limit of quantification to be eligible. In addition, subjects
- •with positive HBsAg should be on anti-HBV therapy at enrollment and while receiving MYTX-011.
- •b. HCV: Subjects with history of HCV infection should have completed curative antiviral treatment and have HCV viral load below the limit of quantification.
- •10. Myocardial infarction, unstable angina, PTCA or CABG or cerebrovascular event (stroke or transient ischemic attack [TIA]) within 6 months before first dose of study drug, symptomatic congestive heart failure (New York Heart Association [NYHA] > Class II; see Appendix B), or ventricular arrhythmias requiring treatment.
- •11. Elevated corrected QT interval (QTc) >480 ms based on Fridericia’s correction formula.
- •12. History of interstitial lung disease or pneumonitis that required treatment with systemic steroids or evidence of active interstitial lung disease or pneumonitis. A history of prior radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •13. Subject requires systemic steroid therapy: prednisone 10 mg daily or equivalent. Inhaled steroids or topical steroid use is permitted.
- •14. Clinically significant systemic illness that could pose undue risk to the subject or confound the ability to interpret study results.
- •15. Active infection requiring IV antibiotics, antivirals, or antifungal medication within 14 days of Cycle 1 Day 1.
- •16. Neuropathy > Grade 1 for any reason.
- •17. History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other
研究者
相似试验
招募中
不适用
Multicenter and dose escalation phase 1 study to evaluate the safety and exploratory efficacy of GC1119 (recombinant human a-galactosidase A) for enzyme replacement therapy in Fabry disease patientsCongenital malformations, deformations and chromosomal abnormalitiesKCT0000597Green Cross10
撤回
1 期
To explore the tolerance and activity of increasing doses of Panobinostat when given in combination with Bortezomib, Cyclophosphamide and Dexamethasone to patients with symptomatic Multiple Myeloma who have had no previous treatment.Multiple Myeloma (Treatment Naive)Cancer - MyelomaACTRN12612000779875orth Shore Haematology Clinical Trial Unit37
进行中（未招募）
1 期
A multicenter phase I/II dose excalation study of lenalidomide in relapse/refractory Waldenström macroglobulinemiaEUCTR2008-006370-15-FRCHRU de Lille
进行中（未招募）
1 期
Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (with and without Bortezomib) in Subjects with Relapsed or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Multiple MyelomaCTIS2023-506110-43-00AbbVie Deutschland GmbH & Co. KG77
招募中
1 期
Study to Understand Safety Efficacy of Novel Stem Cell Formulation to Treat Late Stage Dry Age-related Macular Degeneration (d-AMD)CTRI/2024/04/065639Eyestem Research Pvt. Ltd.