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New treatment option for Advanced Solid Tumor
Official title A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
ClinicalTrials.gov ID: NCT05902988
What this study is testing
What is VLS-1488?
VLS-1488 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to...
- Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian...
- Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor...
You likely can't join if
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previously received KIF18A inhibitor
- Current CNS metastases or leptomeningeal disease
- Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
- Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1...
- Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of...
See the full eligibility criteria
- All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
- Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast...
- Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung...
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previously received KIF18A inhibitor
- Current CNS metastases or leptomeningeal disease
- Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
- Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
- Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug
- Bowel obstruction or GI perforation within 6 months of planned first dose of study drug
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport Beach, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Evanston, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport Beach, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Evanston, Illinois, United States; Indianapolis, Indiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.