Clinical trial · Interventional
MSC2015103B in Solid Tumors
A Phase I Dose-Escalation First-In-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral MEK Inhibitor MSC2015103B Administered With Two Different Treatment Schedules in Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to an administrative reason
Summary
Brief summary (as posted)
The main purpose of this study is to test the experimental drug, MSC2015103B at different dose levels and on different treatment schedules, to see whether it is safe and can be tolerated when given to subjects once a day one day per week over a 21-day period or once a day three times per week over a 21-day period. The investigators would also like to find out how MSC2015103B is broken down by the body. Additional purposes of the trial are to assess side effects of MSC2015103B and to find out whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to explore pharmacokinetics.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSC2015103B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 - MSC2015103B (Schedule 1)
- interventionNames
- Drug: MSC2015103B
- type
- EXPERIMENTAL
- label
- Part 1 - MSC2015103B (Schedule 2)
- interventionNames
- Drug: MSC2015103B
Primary outcomes (2)
- measure
- Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)
- timeFrame
- Up to Day 21 of Cycle 1
- description
- DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (\>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed solid tumor preferably, but not exclusively, including pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma, or melanoma which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1 * Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of and willing to comply with all trial visits and assessments * Evidence of measurable disease at trial entry as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. * Willing to provide archival tissue samples for molecular analysis Other inclusion criteria as defined in protocol. Exclusion Criteria * Bone marrow impairment as evidenced by hemoglobin less than (\<) 9.0 gram per deciliter (g/dL), neutrophil count \< 1.5 x 10\^9 per liter (/L), and/or platelets \<100 x 10\^9/L per liter (/L) * Renal impairment as evidenced by serum creatinine greater than (\>) 1.5 x upper limit of normal (ULN) and/or calculated creatinine clearance \< 50 milliliter per minute (mL/min) (Cockcroft-Gault formula) * Liver function and liver cell integrity abnormality as defined by total bilirubin \> 1.5 x ULN, or aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 2.5 x ULN, for subjects with liver involvement AST/ALT \> 5 x ULN. Subjects with albumin \< 2.5 g/dL are also excluded * History of central nervous system (CNS) metastases. * History of difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product. * Chronic diarrhea that is \>= Grade 2 in severity * Clinically significant cardiac conduction abnormalities * A left ventricular ejection fraction of \< 45% * A history of stroke or myocardial infarction within the past year * A history of uveitis and scleritis * Retinal pathology beyond normal age-related processes * Evidence of a retinal vein occlusion on fluorescein angiogram or a history of retinal vein occlusion * Subjects are also excluded if their ophthalmologist finds that their optic disc is at risk for a central retinal vein occlusion * History of glaucoma * Subjects requiring daily and/or chronic systemic steroids * Pregnant or nursing females Other exclusion criteria as defined in protocol.
References
Publications (0)
Data not yet available