Clinical trial · Interventional
Phase I/II Dose-escalation Study to Investigate Safety and Pharmacokinetics/ Pharmacodynamics of WX-554 in Patients With Solid Tumours
A Phase I/II, Open-label, Dose-escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor WX-554 in Patients With Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated for business reasons
Summary
Brief summary (as posted)
The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of chronic treatment with WX-554.
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 Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WX-554 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WX-554
- interventionNames
- Drug: WX-554
Primary outcomes (3)
- measure
- Part 1: Determination of the Optimal Biological Dose (OBD) by the assessment of ERK phosphorylation (pERK) in peripheral blood mononuclear cells (PBMC) and assessment of TNF-alpha in plasma.
- timeFrame
- Cycle 1 (21 days)
- measure
- Part 1: Determination of the Maximum Tolerated Dose (MTD) for WX-554 by the evaluation of DLTs in 3-6 patients at the end of 1 treatment cycle
- timeFrame
- Cycle 1 (21 days)
- measure
- Part 2: To further determine the safety and tolerability by evaluating the incidence and severity of adverse events and serious adverse events (as per CTCAE grading), changes in hematology and chemistry values, vital signs, ECGs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced, metastatic and/or progressive solid tumours for whom there is no effective standard therapy available. 2. Evaluable or measurable disease 3. Has normal organ functions; is no greater than 2 on the ECOG Performance Scale 4. life expectancy of \>3 months 5. negative hCG test in women of childbearing potential Exclusion Criteria: 1. Patients who received an investigational anti-cancer drug within 4 weeks of starting the study 2. Patients who received major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study 3. Clinically significant, unresolved toxicity from previous anti-cancer therapy Patients 4. Patients who previously received a MEK inhibitor 5. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. 6. Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis. 7. Known HIV positivity or active hepatitis B or C infection. 8. History of clinically significant cardiac condition
References
Publications (0)
Data not yet available