Testing VLS-1488 for advanced cancers
A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer
This study is testing a new oral medication called VLS-1488 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Volastra Therapeutics, Inc. Industry-sponsored |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT05902988 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human phase I/II study designed to evaluate the safety, tolerability, and preliminary efficacy of VLS-1488 in patients with advanced solid tumors. The study consists of two parts: Dose Escalation, which aims to identify the Maximum Tolerated Dose (MTD) through various cohorts, and Dose Expansion, which will further assess safety and efficacy across different tumor types. VLS-1488 will be administered orally in 28-day cycles until disease progression or other stopping criteria are met.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have no available therapeutic options that provide clinically meaningful benefits.
Not a fit: Patients with early-stage cancers or those who have not exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that currently have limited treatment options.
How similar studies have performed: Other studies involving KIF18A inhibitors have shown promise, but this specific approach is novel and untested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion 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 Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial/Uterine * 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 Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine Key Exclusion Criteria: * 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
Where this trial is running
Los Angeles, California and 13 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- Hoag Memorial Hospital — Newport Beach, California, United States (Recruiting)
- University of Colorado Cancer Center — Aurora, Colorado, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Kellogg Cancer Center — Evanston, Illinois, United States (Recruiting)
- Community Health Network — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Active_not_recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Women & Infants Hospital — Providence, Rhode Island, United States (Recruiting)
- M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Volastra Therapeutics, Inc.
- Email: clinicaltrials@volastratx.com
- Phone: (646) 344-1248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.