Actively Recruiting
A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer
Led by Volastra Therapeutics, Inc. · Updated on 2025-11-04
200
Participants Needed
14
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying VLS-1488, an oral drug, in a first-in-human phase I/II trial involving adults with advanced cancers. The study aims to evaluate the safety, tolerability, and early effectiveness of VLS-1488 in different solid tumor types, including ovarian, lung, breast, and endometrial cancers. This includes understanding the drug's effects on tumors with chromosomal instability and exploring its potential in various cancer subtypes. The study has two main parts: Dose Escalation and Dose Expansion. During Dose Escalation, participants receive different doses of VLS-1488 to identify the maximum tolerated dose and appropriate dose levels for further testing. Dose Expansion involves treating participants with selected doses to assess safety, drug interactions, food effects, and preliminary efficacy. VLS-1488 is given orally in 28-day cycles and continued until disease progression or unacceptable side effects occur. Participants will undergo regular evaluations including CT or MRI scans to measure tumor response, safety monitoring for side effects, and assessments of drug levels in the body. Researchers will track dose-limiting toxicities, serious adverse events, and treatment-related side effects up to 18 months, with some measures followed for up to 32 months. Results will help determine how well participants tolerate VLS-1488 and its impact on tumor control over time.
CONDITIONS
Brief Title
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- At least one measurable site of disease by CT or MRI per RECIST 1.1
- Able to take oral medication without changes
- For Dose Escalation: No available effective treatments for specific tumor types including High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, and others listed
- For Dose Expansion: Must have received multiple lines of standard treatment for specified tumor types
You will not qualify if you...
- Presence of MSI-H, dMMR, POLE gene hotspot mutations, or known hypermutator phenotype
- Previous treatment with a KIF18A inhibitor
- Current brain metastases or leptomeningeal disease
- Recent heart attack or stroke within 1 year
- Unstable angina, pulmonary embolism, deep vein thrombosis, or heart surgery within 6 months
- NYHA Class II or higher heart failure or left ventricular ejection fraction below 50%
- Cannot follow medication restrictions related to certain CYP3A and drug transporter inhibitors
- Significant ascites or pleural effusions needing recent medical drainage
- Bowel obstruction or gastrointestinal perforation within 6 months before the study drug start date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 months
Participants receive oral VLS-1488 tablets in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.
Visits occur regularly during each 28-day treatment cycle
Trial Site Locations
Total: 14 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Kellogg Cancer Center
Evanston, Illinois, United States, 60201
Actively Recruiting
6
Community Health Network
Indianapolis, Indiana, United States, 46256
Actively Recruiting
7
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
START Midwest
Grand Rapids, Michigan, United States, 49546
Active, Not Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
13
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
V
Volastra Therapeutics, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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