Multiple clinical trials evaluate tepotinib across Phase 1 through Phase 3 studies, focusing on advanced solid tumors, non-small cell lung cancer harboring MET exon 14 skipping alterations, brain tumors, and healthy subjects to assess pharmacokinetics, safety, and therapeutic efficacy. Sponsored by pharmaceutical companies such as Merck Healthcare KGaA alongside academic medical centers like M.D. Anderson Cancer Center and the Institute of Cancer Research, these protocols test monotherapy and combination regimens. The overall trial portfolio spans completed, actively recruiting, withdrawn, and terminated protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06106802 | RECRUITING | Non-Small Cell Lung Cancer Metastatic |
Samsung Medical Center |
2024-06-11 | PHASE2 |
| NCT07619339 | RECRUITING | Non-Small Cell Lung Cancer |
Memorial Sloan Kettering Cancer Center |
2026-05-27 | PHASE1 |
| NCT06031688 | RECRUITING | Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8 |
SWOG Cancer Research Network |
2024-08-08 | PHASE2 |
| NCT06908993 | RECRUITING | Advanced Non Small Cell Lung Cancer; MET Exon 14 Mutation |
Intergroupe Francophone de Cancerologie Thoracique |
2025-12-09 | PHASE3 |
| NCT05782361 | ACTIVE_NOT_RECRUITING | Advanced Cancer; Non Small Cell Lung Cancer |
Institute of Cancer Research, United Kingdom |
2023-05-03 | PHASE1 |
| NCT06083857 | ACTIVE_NOT_RECRUITING | Non-small Cell Lung Cancer |
M.D. Anderson Cancer Center |
2024-06-18 | PHASE1; PHASE2 |
| NCT02925234 | RECRUITING | Cancer; Tumors; Neoplasm; Neoplasia |
The Netherlands Cancer Institute |
2016-08 | PHASE2 |
| NCT05159245 | RECRUITING | Advanced Cancer; Solid Tumor; Haematological Malignancy |
Helsinki University Central Hospital |
2021-12-10 | PHASE2 |
| NCT05439993 | UNKNOWN | Gastric Cancer; Gastroesophageal-junction Cancer |
Hallym University Medical Center |
2022-03-01 | PHASE1; PHASE2 |
| NCT04591431 | UNKNOWN | Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer |
Fondazione per la Medicina Personalizzata |
2020-10-07 | PHASE2 |
| NCT05120960 | WITHDRAWN | Brain Tumor |
M.D. Anderson Cancer Center |
2023-02-27 | PHASE1 |
| NCT04739358 | TERMINATED | Advanced Non-Small Cell Lung Cancer With MET Mutations |
Criterium, Inc. |
2022-05-25 | PHASE1; PHASE2 |
| NCT03940703 | COMPLETED | Non-small Cell Lung Cancer |
EMD Serono Research & Development Institute, Inc. |
2019-09-19 | PHASE2 |
| NCT05782361 | Recruiting | Advanced Cancer|Non Small Cell Lung Cancer |
Institute of Cancer Research United Kingdom|Merck Serono GmbH Germany|Merck Sharp & Dohme LLC |
2023-05-03 | Phase 1 |
| NCT04647838 | UNKNOWN | Solid Tumor; MET Exon 14 Skipping Mutation; MET Amplification |
Chungbuk National University Hospital |
2020-01-16 | PHASE2 |
| NCT05120960 | Withdrawn | Brain Tumor |
M.D. Anderson Cancer Center |
2023-02-27 | Phase 1 |
| NCT05203822 | COMPLETED | Healthy |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2022-01-21 | PHASE1 |
| NCT02864992 | ACTIVE_NOT_RECRUITING | Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification; Lung Adenocarcinoma Stage IIIB/IV |
EMD Serono Research & Development Institute, Inc. |
2016-09-13 | PHASE2 |
| NCT05213481 | COMPLETED | Healthy |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2021-12-15 | PHASE1 |
| NCT04739358 | Terminated | Advanced Non-Small Cell Lung Cancer With MET Mutations |
Criterium Inc.|EMD Serono Research & Development Institute Inc. |
2022-05-25 | Phase 1|Phase 2 |
| NCT04515394 | TERMINATED | Colorectal Neoplasms |
EMD Serono Research & Development Institute, Inc. |
2021-01-28 | PHASE2 |
| NCT05203822 | Completed | Healthy |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany |
2022-01-21 | Phase 1 |
| NCT05213481 | Completed | Healthy |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany |
2021-12-15 | Phase 1 |
| NCT04204902 | COMPLETED | Healthy |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2019-10-17 | PHASE1 |
| NCT04204902 | Completed | Healthy |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany |
2019-10-17 | Phase 1 |
| NCT03546608 | COMPLETED | Hepatic Impairment |
EMD Serono Research & Development Institute, Inc. |
2018-06-13 | PHASE1 |
| NCT03629223 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2018-08-23 | PHASE1 |
| NCT03628339 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2018-08-20 | PHASE1 |
| NCT03492437 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2018-05-17 | PHASE1 |
| NCT03531762 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2018-05-14 | PHASE1 |
| NCT02115373 | COMPLETED | Carcinoma, Hepatocellular |
Merck KGaA, Darmstadt, Germany |
2014-05-18 | PHASE1; PHASE2 |
| NCT01988493 | COMPLETED | Carcinoma, Hepatocellular |
Merck KGaA, Darmstadt, Germany |
2014-01-06 | PHASE1; PHASE2 |
| NCT01982955 | COMPLETED | Non-small Cell Lung Cancer |
Merck KGaA, Darmstadt, Germany |
2013-12-23 | PHASE1; PHASE2 |
| NCT03021642 | COMPLETED | Healthy |
Merck KGaA, Darmstadt, Germany |
2016-01-31 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-02-23)
Check the
Tepotinib (EMD-1214063)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Tepotinib (EMD-1214063) Solubility in DMSO
- Tepotinib (EMD-1214063) Stock Solution
- Tepotinib (EMD-1214063) Storage
- Tepotinib (EMD-1214063) Stability
- Tepotinib (EMD-1214063) Molecular Weight
- Tepotinib (EMD-1214063) SMILES
- Tepotinib (EMD-1214063) CAS Number
- Tepotinib (EMD-1214063) Chemical Structure (2D and 3D)
- Tepotinib (EMD-1214063) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.