NL-OMON49367已完成不适用
A Phase 1b/2 Study of the Dual MDMX/MDM2 Inhibitor, ALRN-6924, for the Prevention of chemotherapy-induced Myelosuppression - ALRN-6924
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
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
- 18 至 99（—）
入选标准
- •Inclusion Criteria:
- •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 ED SCLC that has recurred or been
- •refractory to one line of treatment with standard platinum-based chemotherapy
- •or immuno-chemotherapy. Patients who received immunotherapy after
- •platinum-based chemotherapy remain eligible.
- •4. Mutated TP53: no wild type (WT) TP 53 gene copies within the tumor (i.e.,
- •biallelic mutation, biallelic deletion, or mutation/deletion), as assessed by
- •next generation sequencing (NGS)
- •5. Measurable disease using RECIST 1.1
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •7. Adequate hematological status:
- •a. absolute neutrophil count (ANC) *1500/*L
- •b. platelet count *100,000/*L
- •c. hemoglobin *9.0 g/dL
- •8. Adequate hepatic and renal function:
- •a. total bilirubin *1.5 X upper limit of normal (ULN) or * 3 X ULN in the
- •presence of Gilbert syndrome or liver metastases
- •b. alkaline phosphatase (ALP), aspartate aminotransferase (AST [SGOT]), and
- •alanine aminotransferase (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)
- •9. Recovery from the acute toxic effects of all prior therapies to Grade *1
- •10. The shorter of 5 half-lives or 4 weeks must have elapsed since any prior
- •systemic therapy, unless no drug-drug interactions with study treatment would
- •be anticipated and the patient had unequivocal radiologic disease progression
- •during the prior line of therapy.
- •11. 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 child-bearing potential) or 6
- •months (female patients of child-bearing potential) following the last dose of
- •study treatment.
排除标准
- •Exclusion Criteria:
- •1. Known hypersensitivity to any component of study treatment including
- •mannitol, which is an excipient in topotecan.
- •2. More than one line of prior chemotherapy for ED SCLC (prior immunotherapy is
- •permitted, concurrent with or subsequent to firstline chemotherapy).
- •Previous treatment with platinum-based chemotherapy concomitant with
- •radiotherapy for limited disease is allowed if completed at least 6 months
- •prior to enrolment into the current trial.
- •3. Presence of active 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.
- •4. Uncontrolled intercurrent illness including but not limited to:
- •a. Clinically significant, active, uncontrolled infection including human
- •immunodeficiency virus (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
- •acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in
- •the past 12 months, and have CD4+ count * 350 cells/*L.
- •ii. Patients with chronic hepatitis B virus (HBV) must be on antiviral
- •therapy and have HBV viral load below the limits of detection.
- •iii. Patients with hepatitis C virus (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
- •5. Clinically significant electrolyte abnormalities
- •6. Clinically unstable cardiac disease, including unstable atrial fibrillation,
- •symptomatic bradycardia, unstable congestive heart failure, active myocardial
- •ischemia, or indwelling temporary pacemaker
- •7. 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.
- •8. Pregnant or lactating women
- •9. Hereditary angioedema of any severity or severe or life-threatening
- •angioedema due to any cause.
- •10. Major surgery (e.G. opening up a mesenchymal barrier) within 28 days of
- •enrolment. Please consult Medical monitor as needed
- •11. Significant weight loss (*15% body weight) within the 4 weeks prior to
- •12. Treatment with an investigational agent for any indication within the
- •shorter of 14 days or 5 half-lives, if the half-life is known
- •13. The required use of any concomitant medications that are predominantly
- •cleared by hepatobiliary transporters, organic anion transporter polypeptide
- •[OATP] members OATP1B1 and OATP1B3 on the day of the first ALRN-6924 infusion
- •to within 48 hours after the last ALRN-6924 infusion in a treatment cycle (see
- •Appendix A)
- •14. Other medications, severe acute/chronic medical or psychiatric condition,
- •or laboratory abnormality that may increase the risk associated with study
- •participation or study drug administration, or may interfere with the
- •interpretation of study results, and in the judgment of the investigator would
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研究者
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