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临床试验/EUCTR2019-002409-23-NL
EUCTR2019-002409-23-NL进行中（未招募）1 期

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability,Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patientswith Locally-Advanced or Metastatic Non-Small Cell Lung Cancer HarboringEGFR Exon 20 Insertion Mutations who have Previously Received Platinum-Based Systemic Chemotherapy - CLN-081 in exon 20 mutant NSCLC

Cullinan Oncology Inc.0 个研究点目标入组 369 人开始时间: 2019年10月14日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
369
研究概览入排标准研究者记录与标识符相似试验

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. Histologically or cytologically confirmed locally advanced or
  • •metastatic NSCLC (all patients). For module A only, histologically or
  • •cytologically confirmed solid tumor with the exception of esophageal,
  • •gastric, pancreatic, hepatobiliary, or small bowel carcinomas, or history of gastric resection.
  • •2. Documented EGFR exon 20 insertion (ex20ins) mutation
  • •demonstrated by a validated test (per protocol) and performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory (all patients other than Module A Food Effect PK Assessment Module).
  • •3. Prior treatment in the recurrent/metastatic disease setting including:
  • •a. A platinum-based chemotherapy regiment (or other chemotherapy
  • •regimen if platinum-based chemotherapy is contra-indicated)
  • •b. Any other approved standard therapy that is available to the patient,
  • •unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.
  • •c. No prior therapy is required for patients enrolled on Module A.
  • •d. Prior therapy with an agent approved by the local regulatory authorities for the treatment of EGFR ex20ins mutant NSCLC (Module C only).
  • •4. Measurable disease by Response Evaluation Criteria in Solid Tumors
  • •(RECIST) 1.1 (except for patients enrolled on Module A).
  • •5. Age = 18 years.
  • •6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or
  • •7. Ability to take pills by mouth.
  • •8. Have the following laboratory values:
  • •a. Serum creatinine < 1.5 × upper limit of normal (ULN) or if higher than
  • •normal range, calculated creatinine clearance (CrCl) must be = 50 mL/min/1.73 m2 (if calculated by Cockroft-Gault formula, the actual body weight must be used for CrCl unless body mass index [BMI] >30 kg/m2 then lean body weight must be used).
  • •b. Total bilirubin = 1.5 × ULN unless prior history of Gilbert's syndrome.
  • •c. AST and ALT = 2.5 × ULN, or = 5 × ULN if due to liver involvement by
  • •d. Hemoglobin = 9.0 g/dL in the absence of transfusion = 14 days prior
  • •to the first dose of study drug on C1D1.
  • •e. Platelets = 100 × 10E9 cells/L in the absence of transfusion <14 days
  • •prior to the first dose of study drug on Cycle 1 Day 1 (C1D1).
  • •f. Absolute neutrophil count = 1.5 ×10E9 cells/L.
  • •9. For Module A patients only: patients must have a negative coronavirus
  • •disease 2019 (COVID-19) polymerase chain reaction test prior to
  • •10. For Module B and Module C patients only: verification of suitable
  • •archived tumor tissue available at the participating center for biomarker analysis. A fresh biopsy is required if an archived sample is not available.
  • •11. Ability to understand and the willingness to sign a written informed
  • •consent document.
  • •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 185
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 184

排除标准

  • •R6, Phase 1 Expansion, Phase 2a, Module A and Module B Patients Only
  • •1. Prior treatment with an EGFR ex20ins-targeting drug (see protocol for
  • •examples). Note: enrolment of patients treated previously with EGFR ex20ins-targeting drugs allowed selectively during accelerated titration dose escalation and Module C only.
  • •Module A Patients Only
  • •2. Conditions that compromise esophageal or gastrointestinal (GI)
  • •3. Recurrent diarrhea, nausea, or vomiting.
  • •4. Unable to refrain from or anticipates use of any drug, including
  • •prescription and non-prescription medications (see protocol) for the periods defined in the protocol.
  • •5. Any allergies to the composition of the high fat meal.
  • •6. Patients who use tobacco products.
  • •All Patients
  • •7. History of COVID-19-related pneumonitis requiring hospitalization.
  • •8. History of COVID-19 infection within 4 weeks prior to enrolment, or
  • •clinically significant pulmonary symptoms related to prior COVID-19
  • •pneumonitis.
  • •9. Treatment with any of the following:
  • •a. An EGFR TKIs = 8 days or 5 x the terminal phase elimination halflives,
  • •whichever is longer, prior to first dose of study drug on C1D1
  • •b. Systemic anticancer treatment (excluding EGFR-TKIs as described
  • •above) within 14 days prior to the first dose of study drug on C1D1.
  • •c. Immunotherapy = 28 days prior to the first dose of study drug on
  • •d. Radiotherapy = 28 days and palliative radiation = 14 days prior to the first dose of study drug on C1D1. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.
  • •e. Major surgery (excluding placement of vascular access) = 28 days of the first dose of study drug on C1D1.
  • •10. Have any unresolved toxicity of Grade = 2 from previous anti-cancer
  • •treatment, except for alopecia and skin pigmentation. Patients with chronic but stable Grade 2 toxicities may be allowed to enrol after
  • •agreement between the Investigator and Sponsor.
  • •11. Have known or suspected leptomeningeal metastasis. Have known or suspected brain metastases or spinal cord compression, unless the
  • •condition has been asymptomatic, treated with surgery and/or radiation (if clinically indicated), and has been stable without requiring escalating corticosteroids or anti-convulsant medications for at least four weeks prior to the first dose of study drug on C1D1.
  • •12. Prior therapy with CLN-081.
  • •13. Known hypersensitivity to CLN-081 or any drugs similar in structure or class.
  • •14. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, treatment-related pneumonitis, or any evidence of clinically active interstitial lung disease.
  • •15. Cardiac conditions as follows: Patient has a history of CHF Class
  • •III/IV according to the NYHA Functional Classification or serious cardiac arrhythmias requiring treatment.
  • •16. Resting QTcF > 470 msec.
  • •17. Patient is unable to take drugs orally due to disorders or diseases
  • •that may affect GI function,including but not limited to inflammatory
  • •bowel diseases or
  • •malabsorption syndrome, or procedures that may affect gastrointestinal
  • •function, such as gastrectomy, enterectomy, or colectomy.
  • •18. Have any condition or illness that, in the opinion of the Investigator,
  • •might compromise patient safety or interfere with the evaluation of the
  • •safety of the drug.
  • •19. Pregnant or lactating females; FOCBP must have a negative serum
  • •pregnancy test at within seven days prior to receiving study drug on

研究者

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