Clinical trial · Interventional
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors
A Japanese Multicenter, Open Label, Phase I Trial of c-Met Inhibitor MSC2156119J Given Orally as Monotherapy to Subjects With Solid Tumors
NCT01832506CI-TRIAL-00046481completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSC2156119J | Drug | Tepotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MSC2156119J
- interventionNames
- Drug: MSC2156119J
Primary outcomes (1)
- measure
- Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
- timeFrame
- Cycle 1 (Day 1 up to 21)
- description
- DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (\>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; \>=Grade 3 nausea despite adequate treatment; \>=Grade 3 any non-hematological AE (DLT defined specifically for following cases: \>=Grade 3 liver adverse event \[AE\] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; \>=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of \>=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and \>=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * A subject with a histologically or cytologically confirmed diagnosis of malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable * An archived tumor tissue is available or biopsy of tumor tissues can be newly performed * A Japanese male or female, age greater than or equal to (\>=) 20 years * A subject who has read the Subject Information Sheet and understood the details of this clinical trial, and is willing and able to give his/her informed consent. * A female of child-bearing potential must have a negative blood pregnancy test result at her screening period. A female subject of child-bearing potential must be willing to avoid pregnancy by using an adequate method of contraception Life expectancy is at least 3 months * Other inclusion criteria apply Exclusion Criteria: * Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B * Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed * Signs or symptoms that suggest transmissible spongiform encephalopathy * Received major surgery within 6 weeks before Day 1 in Cycle 1 * Known drug abuse or alcohol abuse * Known hypersensitivity to any of the trial treatment ingredients * Hematological test abnormalities * Renal impairment as defined in the protocol * Liver dysfunction as defined in the protocol * History or presence of central nervous system metastasis * History or presence of disease or condition that may hamper compliance or absorption of the investigational medicinal product (IMP) due to difficulty in swallowing or absorption * Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG PS) \>= 2 * Received any anti-cancer therapy days Received extensive prior radiotherapy that irradiates more than 30 percent of bone marrow * Received any radiotherapy within 4 weeks before Day 1 in Cycle 1 * Pregnancy and lactation period * History of receiving treatment with any c-Met signaling pathway inhibitor * Participation in another interventional clinical trial within the past 30 days from Day 1 in Cycle 1 * Other significant disease that in the Investigator's opinion would exclude the subject from the trial * Legal incapacity or limited legal capacity * Other exclusion criteria apply
References
Publications (2)
- RESULTShitara K, Yamazaki K, Tsushima T, Naito T, Matsubara N, Watanabe M, Sarholz B, Johne A, Doi T. Phase I trial of the MET inhibitor tepotinib in Japanese patients with solid tumors. Jpn J Clin Oncol. 2020 Aug 4;50(8):859-866. doi: 10.1093/jjco/hyaa042. PMID 32328660
- DERIVEDXiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30. PMID 35771259