Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05902988

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

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Volastra Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion. Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumor types at various dose levels through a series of Dose Escalation and Backfill Cohorts to identify the Maximum Tolerated Dose (MTD) and to select dose levels for Dose Expansion. The criteria for dose (de-)escalation will be based on a Bayesian Optimal Interval (BOIN) design. Dose Expansion will examine the safety, tolerability, Drug Drug Interaction (DDI) risk, Food Effect (FE) and preliminary efficacy of VLS-1488 in different tumor types and/or dose levels of interest through various expansion cohorts. VLS-1488 will be given orally in 28-day cycles. Dosing will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

Conditions

Interventions

TypeNameDescription
DRUGVLS-1488VLS-1488 tablets will be given orally.

Timeline

Start date
2023-10-18
Primary completion
2026-06-01
Completion
2026-12-01
First posted
2023-06-15
Last updated
2025-11-04

Locations

14 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05902988. Inclusion in this directory is not an endorsement.