Clinical trial · Interventional
Dose Escalation Study in Acute Myeloid or B-Cell Acute Lymphoblastic Leukemia
A Phase I Dose Escalation Study of VS-4718, A Focal Adhesion Kinase Inhibitor, In Subjects With Relapsed or Refractory Acute Myeloid Leukemia or B-Cell Acute Lymphoblastic Leukemia
- 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)
The main purpose of this study is to test the safety and efficacy of VS-4718 in two types of leukemia patients and to find the right dose of VS-4718 for future clinical trials. Other purposes of this study include: * Testing for study drug VS-4718 levels in blood over time and what happens to the study drug in patients. * To find out if there are certain biomarkers in leukemia patients that predict if and how 4718 study drug may or may not work.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Acute Myeloid Leukemia | — | UNRESOLVED | — |
| Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VS-4718 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental VS4718
- description
- Oral VS-4718 administered BID during a 28 day cycle.
- interventionNames
- Drug: VS-4718
Primary outcomes (2)
- measure
- To find the maximum tolerated dose of VS-4718
- timeFrame
- Dose Escalation will occurr according to the standard 3+3 design where three subjects are dosed with the same dosage in the first Cycle (of 28 days); subjects will be evaluated for DLTs on Days: 1, 8, 15, 22 and 28 of first Cycle
- description
- In the absence of a dose limiting toxicity (DLT), each subject will receive VS-4718 for a minimum of 28 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles until disease progression or other treatment discontinuation criteria have been met. It is estimated that subjects could potentially receive VS-4718 for up to an additional 2-3 cycles before withdrawal criteria apply.
- measure
- Safety and Tolerability of VS-4718 Measurements
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Pathologic confirmation of AML or B-ALL * Must have relapsed or refractory AML or B-ALL with no alternate therapy of proven benefit * ECOG status of 0 or 1 * Adequate renal function \[creatinine less than or equal to 1.5x ULN\] or GFR of at least 60mL/min * Adequate hepatic function via total bilirubin, AST, and ALT * Corrected QT interval of less than 470 ms (via Fridericia correction formula) * Negative pregnancy test for women of child bearing potential * Willingness to use adequate birth control throughout participation for both men and women Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia * Active grade 2 or higher acute GVHD at time of study entry or active chronic GVHD (moderate or severe) * Gastrointestinal conditions which could interfere with the swallowing or absorption of study medication * Diagnosis of currently active CNS leukemia * Known infection with HIV or AIDS (testing not required) * Known active Hepatitis A, B or C (testing not required) * Patients being actively treated for a secondary malignancy * Cancer-directed therapy within 14 days of the first dose of study drug or 5 half-lives, whichever is longer * Major surgery within 28 days prior to the first dose of study drug * Use of an investigational drug within 28 days or 5 half-lives whichever is longer * Women who are pregnant or breastfeeding * Evidence of uncontrolled infections requiring antibiotic therapy; potential subjects with known or suspected infections on stable antibiotic therapy for 72 hours may be enrolled * Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (0)
Data not yet available