Actively Recruiting
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
Led by Volastra Therapeutics, Inc. · Updated on 2025-11-04
200
Participants Needed
14
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 disease site by CT scan or MRI per RECIST 1.1
- Able to take oral medication without alteration
- Dose Escalation participants have no available therapeutic options for specific tumor types including high grade serous ovarian cancer, squamous non-small cell lung cancer, triple negative breast cancer, gastric adenocarcinoma (not EBV+), colorectal, esophageal squamous cell carcinoma, esophageal adenocarcinoma, gastroesophageal junction, bladder (transitional cell), head and neck squamous cell carcinomas (excluding nasopharynx, sinonasal or lip), ovarian carcinosarcoma, and CN-high endometrial/uterine cancers
- Dose Expansion participants must have been treated with several lines of standard care for the specified tumor types
You will not qualify if you...
- MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
- Previous treatment with a KIF18A inhibitor
- Current central nervous system metastases or leptomeningeal disease
- Cardiac issues including myocardial infarction or stroke within 1 year, unstable angina, pulmonary embolism, deep vein thrombosis, or coronary artery bypass graft within 6 months, New York Heart Association Class II or higher, or left ventricular ejection fraction below 50%
- Unable to comply with medication restrictions regarding strong CYP3A inhibitors/inducers or clinical inhibitors of MDR1 (P-gp) and BCRP
- Clinically significant ascites or pleural effusions at enrollment, or any therapeutic fluid drainage within 28 days before first dose
- Bowel obstruction or gastrointestinal perforation within 6 months before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
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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