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Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR TEPOTINIB HYDROCHLORIDE


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All Clinical Trials for Tepotinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01014936 ↗ First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors Completed Merck KGaA Phase 1 2009-11-30 This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01014936 ↗ First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors Completed Merck KGaA, Darmstadt, Germany Phase 1 2009-11-30 This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01014936 ↗ First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors Completed EMD Serono Phase 1 2009-11-30 This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
NCT01982955 ↗ Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) Completed Merck KGaA Phase 1/Phase 2 2013-12-23 This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).
NCT01982955 ↗ Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) Completed Merck KGaA, Darmstadt, Germany Phase 1/Phase 2 2013-12-23 This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tepotinib Hydrochloride

Condition Name

Condition Name for Tepotinib Hydrochloride
Intervention Trials
Healthy 8
Carcinoma, Hepatocellular 2
Non-small Cell Lung Cancer 2
Colorectal Neoplasms 1
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Condition MeSH

Condition MeSH for Tepotinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 4
Lung Neoplasms 3
Carcinoma, Hepatocellular 2
Carcinoma 2
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Clinical Trial Locations for Tepotinib Hydrochloride

Trials by Country

Trials by Country for Tepotinib Hydrochloride
Location Trials
United States 60
Germany 14
China 13
France 11
Russian Federation 8
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Trials by US State

Trials by US State for Tepotinib Hydrochloride
Location Trials
Texas 5
Florida 4
Washington 3
New York 3
Georgia 3
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Clinical Trial Progress for Tepotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tepotinib Hydrochloride
Clinical Trial Phase Trials
Phase 2 4
Phase 1/Phase 2 4
Phase 1 11
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Clinical Trial Status

Clinical Trial Status for Tepotinib Hydrochloride
Clinical Trial Phase Trials
Completed 11
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Tepotinib Hydrochloride

Sponsor Name

Sponsor Name for Tepotinib Hydrochloride
Sponsor Trials
Merck KGaA, Darmstadt, Germany 14
Merck KGaA 10
EMD Serono Research & Development Institute, Inc. 5
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Sponsor Type

Sponsor Type for Tepotinib Hydrochloride
Sponsor Trials
Industry 34
Other 2
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