RecruitingPhase 1Phase 2NCT05902988

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer


Sponsor

Volastra Therapeutics, Inc.

Enrollment

200 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study is testing VLS-1488, a new oral anticancer drug, in adults with various types of advanced solid tumors that have stopped responding to standard treatments. The study first tests safety at increasing doses, then expands to specific cancer types. **You may be eligible if...** - You are 18 or older with good general health (ECOG ≤1) - You have at least one measurable tumor on CT or MRI - You can swallow oral medication - Your cancer is one of the eligible types, including: high-grade serous ovarian cancer, squamous non-small cell lung cancer, triple-negative breast cancer, gastric adenocarcinoma, colorectal, esophageal, bladder, head and neck squamous cell, or certain endometrial cancers - You have received standard treatments that are no longer working **You may NOT be eligible if...** - You have significant heart, liver, or kidney problems - You have untreated or unstable brain metastases - You are pregnant or breastfeeding - You are taking medications that cannot be safely combined with VLS-1488 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVLS-1488

VLS-1488 tablets will be given orally.


Locations(14)

University of Southern California

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Kellogg Cancer Center

Evanston, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Women & Infants Hospital

Providence, Rhode Island, United States

M.D. Anderson Cancer Center

Houston, Texas, United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05902988


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