Clinical trial · Interventional
Phase I Dose Escalation Study of VS-4718 in Subjects With Metastatic Non-Hematologic Malignancies
A Phase I Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Subjects With Metastatic Non-Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision to deprioritize the program.
Summary
Brief summary (as posted)
This is a Phase I, open-label, multicenter, dose-escalation trial of VS-4718, a focal adhesion kinase inhibitor, in subjects with metastatic non-hematologic malignancies. This clinical study is comprised of 2 parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-4718 in your blood) and the anti-cancer activity of VS-4718. The pharmacodynamic effects (genes or proteins that may predict or show how your body may respond to VS-4718) will also be examined in tumor biopsies and blood samples.
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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Non Hematologic Cancers | Non-Hematologic Malignancy | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VS-4718 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VS-4718
- description
- Oral VS-4718 administered BID (QD during first cohort) during a 28 day cycle.
- interventionNames
- Drug: VS-4718
Primary outcomes (2)
- measure
- Assess the safety and tolerability of VS-4718 in subjects with metastatic non-hematologic malignancies
- timeFrame
- Expected average of 12 weeks from start of treatment to end of treatment
- description
- Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety monitoring committee will review safety information.
- measure
- Establish the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of VS-4718 in subjects with metastatic non-hematologic malignancies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Histopathologically confirmed diagnosis of a metastatic non-hematologic malignancy. * ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 * Adequate renal function * Adequate hepatic function (total bilirubin ≤ 1.5x ULN (upper limit of normal) for the institution; AST \[aspartate transaminase\] and ALT \[alanine transaminase\] ≤ 3x ULN, or ≤ 5x ULN if due to liver involvement by tumor). * Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100 x10 9 cells/L; absolute neutrophil count ≥ 1.5x10 9 cells/L * Corrected QT interval (QTc) \< 470 ms * Subjects must have at least one tumor lesion that is suitable for repeat biopsy, and must agree to two tumor biopsies (pre- and post- treatment). * Willing and able to participate in the trial and comply with all trial requirements. Exclusion Criteria: * Gastrointestinal (GI) condition which could interfere with the swallowing or absorption of study medication. * Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases). * History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months. * Known history of stroke or cerebrovascular accident within 6 months. * Subjects being actively treated for a secondary malignancy.
References
Publications (0)
Data not yet available