EUCTR2019-001848-21-IT进行中（未招募）1 期
A Phase 1b/2 Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of Chemotherapy-induced Myelosuppression - ALRN-6924
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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. Males and females age 18 years or older.
- •2. Ability to understand the requirements of this clinical trial and
- •willingness to provide written informed consent.
- •3. Histopathological confirmation of Stage IV NSCLC of adenocarcinoma
- •histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor
- •tissue is available for p53
- •mutation analysis. FDA approved liquid biopsies are also acceptable.
- •4. Presence of p53 mutation(s) in tumor tissue or circulating cell free
- •DNA as assessed by NGS.
- •5. Patients who are deemed to be good candidates for chemotherapy XML File Identifier: 7oX6DHVPgyQjU1GVcEKw4WAEkKA=
- •with carboplatin and pemetrexed, OR standard immunochemotherapy
- •that includes carboplatin and pemetrexed, with a planned delivery of at
- •least 4 chemotherapy treatment cycles. Concurrent use of
- •bevacizumab as per local treatment practice is permitted.
- •6. No prior systemic therapy for any stage NSCLC, including
- •chemotherapy, immunotherapy or targeted drugs (e.g., inhibitors of
- •EGFR, ALK, ROS, RET, HER2, BRAF etc.).
- •7. Absence of tumor genomic aberrations of EGFR, ALK or other
- •actionable genomic aberrations, as per local standard of care.
- •8. Measurable disease using RECIST 1.1
- •9. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •10. Adequate hematological status without supportive care measures
- •during screening period:
- •a. ANC =1500/µL
- •b. platelet count =100,000/µL
- •c. hemoglobin =9.0 g/dL
- •11. Adequate hepatic and renal function:
- •a. total bilirubin =1.5 X ULN or = 3 X ULN in the presence of Gilbert
- •syndrome or liver metastases
- •b. ALP, AST (SGOT), and ALT (SGPT) = 2.5 X ULN in the absence of liver
- •c. ALP, AST (SGOT), and ALT (SGPT) =5 X ULN in the presence of liver
- •d. serum creatinine <1.5 X ULN or calculated creatinine clearance = 40
- •mL/min (C&G or EDTA)
- •12. Males and female patients of child-bearing potential must agree to
- •use an acceptable method of birth control for the duration of study
- •treatment and for 3 months (male patients with female partner of childbearing potential) or 6 months (female patients of child-bearing
- •potential) following the last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. Known hypersensitivity to any component of study treatment. 2. Presence of active and symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, with no evidence of radiographic or neurologic progression during the
- •screening period and no requirement for steroids for at least 15 days before enrolment. 3. Advanced NSCLC tumors with EGFR mutations or ALK re-arrangement or other actionable genetic aberrations for which an approved targeted treatment is available. Patients who received prior treatment with EGFR or ALK inhibitors or other systemic drugs or immunotherapy for NSCLC are not eligible for participation. 4. Patients who are candidates for anti-PD-1 monotherapy in 1st line advanced NSCLC (e.g., tumors with high PD-L1 expression). 5. Patients who received prior systemic treatment for earlier stage NSCLC disease other than surgery, immunotherapy and/or localized radiotherapy. Patients who received neoadjuvant or adjuvant chemotherapy, or radiochemotherapy are not eligible for participation. 6. Patients who require growth factor or transfusion support of hematologic function during the screening period. Rescreening is not permitted for patients who do not meet criteria for adequate
- •hematologic status. 7. Uncontrolled intercurrent illness including but not limited to: a. Clinically significant, active, uncontrolled infection including HIV, or hepatitis B or C i. Patients with HIV must be on effective antiretroviral therapy for = 4
- •weeks prior to enrollment and have HIV viral load < 400 copies/mL, have had no AIDS-defining opportunistic infections in the past 12 months, and have CD4+ count = 350 cells/µL. ii. Patients with chronic HBV must be on antiviral therapy and have HBV viral load below the limits of detection. iii. Patients with HCV must be on or have completed antiviral therapy and have an HCV viral load below the limits of detection. b. Uncontrolled hypertension c. Uncontrolled diabetes mellitus 8. Serum albumin <30 g/L 9. Clinically significant electrolyte abnormalities 10. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker 11. History of prior malignancy; patients with a known malignancy that does not affect overall well-being and ability to participate in the study can be considered in consultation with the Medical Monitor. 12. Pregnant or lactating women
- •13. Hereditary angioedema of any severity or severe or life-threatening angioedema due to any cause. 14. Major surgery (e.g., opening up a mesenchymal barrier) within 28 days of enrolment. Please consult Medical Monitor as needed.15. Significant weight loss (=10% body weight) within the 4 weeks prior to enrolment. 16. Treatment with an investigational agent for any indication within the shorter of 14 days or 5 half-lives, if the half-life is known.17. The required use of any concomitant medications that are predominantly cleared by hepatobiliary transporters, OATP members OATP1B1 and OATP1B3 on the day of the first ALRN-6924 infusion to within 24 hours after the last ALRN-6924 infusion in a treatment cycle (see Appendix A).18. Other medications, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participa
研究者
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