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临床试验/NL-OMON56206
NL-OMON56206招募中不适用

Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics , Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy - CLN-081-001 (REZILIENT1)

Cullinan Oncology Inc.0 个研究点目标入组 32 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
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

入排标准

年龄范围
18 至 99（—）

入选标准

  • •A patient who meets all of the following inclusion criteria will be eligible to
  • •participate in this study:
  • •1. Histologically or cytologically confirmed recurrent and/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
  • •2. Documented EGFR exon 20 insertionex20ins mutation demonstrated by a
  • •validated test routinely used by each institutionlisted in Section 9.7 and
  • •performed in a Clinical Laboratory Improvement Amendments (CLIA-)-certified or
  • •equivalent laboratory (all patients other than Module A Food Effect PK
  • •Assessment Module). Institutions that don*t have access to these tests should
  • •contact the sponsor for assistance.
  • •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 1.
  • •7. Ability to take pills by mouth.
  • •8. Have the following laboratory values:
  • •a. Serum creatinine < 1.5 × ULNupper 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
  • •b. Total bilirubin <= 1.5 × ULN unless prior history of Gilbert*s syndrome.
  • •c. Aspartate transaminase and alanine transaminaseAST and ALT <= 2.5 × ULN, or <=
  • •5 × ULN if due to liver involvement by tumor.
  • •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 × 109 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 ×109 cells/L.
  • •9. For Module A patients only: patients must have a negative coronavirus
  • •disease 2019 (COVID 19) polymerase chain reaction test prior to enrolment.
  • •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 and comply with study procedures.

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 (eg, including, but not
  • •limited to poziotinib, mobocertinib, amivantamab, DZD9008, BDTX-189).
  • •Note: enrolment of patients treated previously with EGFR ex20ins targeting
  • •drugs allowed selectively during accelerated titration dose escalation and
  • •Module C only.
  • •Module A Food Effect PK Assessment Module patients only
  • •2. Conditions that compromise esophageal or GI function, including esophageal,
  • •gastric, hepatobiliary, or small bowel carcinomas or history of gastric
  • •3. Recurrent diarrhea, nausea, or vomiting.
  • •4. Unable to refrain from or anticipates the use of:
  • •a. Any drug, including prescription and non-prescription medications, including
  • •drugs that change gastrointestinal motility (eg, loperamide) or gastric pH (eg,
  • •antacids, H2 antagonists, proton pump inhibitors), herbal remedies, or vitamin
  • •supplements within 14 days prior to the first dosing on Day 1 to follow-up.
  • •b. Any drugs known to be inhibitors or inducers of cytochrome P450 (CYP)3A
  • •enzymes and/or p-glycoprotein (P-gp), including St. John*s Wort and grapefruit
  • •juice, within 28 days prior to the first dosing and throughout the PK
  • •assessment.
  • •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, have
  • •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 × the terminal phase elimination half-lives,
  • •whichever is longer, prior to the first dose of study drug on C1D1
  • •b. Systemic anticancer treatment (excluding EGFR TKIs as described above) <= 14
  • •days prior to the first dose of study drug on C1D1.
  • •c. 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.
  • •d. Immunotherapy <= 28 days prior to the first dose of study drug on C1D1.
  • •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 enroll 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
  • •14. Past medical history of interstitial lung disease, treatment-related
  • •pneumonitis, or any evidence of clinically active interstitial lung disease.
  • 另有 1 项未显示

研究者

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