Phase III Study of Oral VLS-1488 for Safety and Early Effectiveness in Advanced Cancers

What this Trial Is About

Researchers are studying VLS-1488, an oral drug, in a first-in-human phase III 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 drugs 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.

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