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

Description

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.

Conditions

Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Transitional Cell Carcinoma of Bladder, Head and Neck Squamous Cell Carcinoma, Ovarian Carcinosarcoma, Uterine Carcinosarcoma, Uterine Serous Carcinoma, Endometrium Cancer, Chromosomal Instability

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Aurora

University of Colorado Cancer Center, Aurora, Colorado, United States, 80045

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06511

Indianapolis

Community Health Network, Indianapolis, Indiana, United States, 46256

Baltimore

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States, 21224

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cincinatti

The Christ Hospital, Cincinatti, Ohio, United States, 45219

Providence

Women & Infants Hospital, Providence, Rhode Island, United States, 02905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
  • * Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial/Uterine
  • * Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine
  • * MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
  • * Previously received KIF18A inhibitor
  • * Current CNS metastases or leptomeningeal disease
  • * Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
  • * Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
  • * Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug
  • * Bowel obstruction or GI perforation within 6 months of planned first dose of study drug

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Volastra Therapeutics, Inc.,

Study Record Dates

2026-06