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Tepotinib - ClinicalTrials.gov

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Last Updated: 13 January 2022

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A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors

To identify the advised phase II dosage of tepotinib for patients with brain metastasis and MET changes B. To establish RP2D of tepotinib in patients with GLIOBLASTOMA with MET alterations C. To figure out RP2D of tepotinib in combination with osimertinib in patients with EGFR+ NSCLC with EGFR TKI resistance and MET boosting Phase 1b: A. To figure out intracranial professional benefit of tepotinib in brain mets, as measured by RANO-BM, in patients with NSCLC and METex14-skipping mutations C. To determine intracranial professional benefit of tepotinib in combination with osimertinib, in brain transition, as determined by RANO-BM, in patients with EGFR+ NSCLC with EGFR TKI resistance and MET amplification 2. 2 Secondary Objectives: Phase 1a: A1. To examine the security and toxicity of tepotinib in dealing with brain metastasis in patients with MET changes in Group A, as gauged by CTCAE, version 5. 0 A2. To assess the PK/PD of tepotinib in brain metastasis tissue and CSF in patients with MET modifications in Group A A3. To assess the PK/PD of tepotinib in glioblastoma tissue and CSF in patients with MET changes in Group B B3. To identify objective response rate according to RANO of Group B B5. To identify the duration of response by RANO in Group B B6. To assess the PK/PD of tepotinib in CSF in patients with EGFR+ NSCLC with EGFR TKI resistance and MET amplification treated with the combination of osimertinib and tepotinib C3. To establish progression-free survival for intracranial condition and extracranial illness in Group A A5. To determine the site of first progression in Group A A8. To determine the period of intracranial response by BM-RANO and by mRECIST in Group A A9. To discover the patient experience with treatment utilizing patient-reported results making use of the MDASI-BT and EQ-5D-5L sets of questions in Group A A12. To examine the safety and security andtoxicity as determined by CTCAE, variation 5. 0, in patients with EGFR+ NSCLC with EGFR TKI resistance and MET boosting C2. To review the PK/PD of tepotinib in CSF in patients with EGFR TKI resistance and MET amplification C3. To determine the site of first progression in Group C C8. To figure out the duration of intracranial response by BM-RANO and by mRECIST in Group C C9. To explore the patient experience with therapy utilizing patient-reported outcomes utilizing the MDASI-BT and EQ-5D-5L sets of questions in Group C C12.

Source link: https://clinicaltrials.gov/ct2/show/NCT05120960

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions