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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Solid Tumor
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Transitional Cell
  • Carcinosarcoma
  • Chromosomal Instability
  • Colorectal Adenocarcinoma
  • Endometrial Neoplasms
  • Endometrium Cancer
  • Esophageal Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Mixed Tumor, Mullerian
  • Ovarian Carcinosarcoma
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Non-small-cell Lung Cancer
  • Transitional Cell Carcinoma of Bladder
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Carcinosarcoma
  • Uterine Serous Carcinoma

NCT number NCT05902988
Study type Interventional
Source Volastra Therapeutics, Inc.
Contact Volastra Therapeutics, Inc.
Phone (646) 344-1248
Email clinicaltrials@volastratx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date October 18, 2023
Completion date June 2026

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