Study on VLS-1488 for Patients with Advanced Cancer

Sponsor: Volastra Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05902988

Provider View

This clinical trial is testing a new drug, VLS-1488, to see if it is safe and effective for treating advanced cancers. The study is divided into two parts: testing different doses and expanding to more patients once a safe dose is found.

Patient Parameters

Program Overview

This study is the first time VLS-1488 is being tested in humans. It aims to find out if the drug is safe and how well it works for people with advanced cancers. The study has two parts: the first part tests different doses to find the safest and most effective one, while the second part uses this dose to treat more patients and gather more information about the drug's effects. VLS-1488 is taken by mouth in 28-day cycles and treatment continues until the cancer worsens, side effects become too severe, or the patient decides to stop.

Description

The study is divided into two main parts: Dose Escalation and Dose Expansion.

In the Dose Escalation part, researchers will test VLS-1488 at different dose levels in patients with various types of solid tumors. The goal is to find the highest dose that can be given safely, known as the Maximum Tolerated Dose (MTD). This part will help determine the best dose levels to use in the next phase of the study.

In the Dose Expansion part, the study will further explore the safety and effectiveness of VLS-1488 at the selected dose levels. Researchers will also look at how the drug interacts with other medications and how food affects its absorption. This part will involve patients with specific types of cancer who have already tried several standard treatments.

Participants will take VLS-1488 orally in 28-day cycles. Treatment will continue until the cancer progresses, side effects become unacceptable, the patient withdraws consent, or other criteria for stopping treatment are met.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have at least one measurable tumor that can be tracked using CT or MRI scans.
  • Must be able to take oral medication without any changes.
  • For Dose Escalation: Must have no other treatment options that provide meaningful benefits for specific types of cancer, such as high-grade serous ovarian cancer, squamous non-small cell lung cancer, triple-negative breast cancer, and others.
  • For Dose Expansion: Must have previously received several standard treatments for specific types of cancer, such as high-grade serous ovarian cancer, squamous non-small cell lung cancer, triple-negative breast cancer, and others.

Exclusion Criteria

  • Have certain genetic mutations or known hypermutator phenotype.
  • Have previously received a KIF18A inhibitor.
  • Have current cancer spread to the brain or spinal fluid.
  • Have recent heart attack, stroke, or severe heart conditions.
  • Cannot comply with medication restrictions related to certain drug interactions.
  • Have significant fluid buildup in the abdomen or chest, or have had fluid drained within 28 days before starting the study.
  • Have bowel obstruction or gastrointestinal perforation within 6 months before starting the study.

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