RECRUITING

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

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Conditions

Advanced Solid TumorHigh Grade Serous Adenocarcinoma of OvarySquamous Non-small-cell Lung CancerTriple Negative Breast CancerGastric AdenocarcinomaColorectal AdenocarcinomaEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaTransitional Cell Carcinoma of BladderHead and Neck Squamous Cell CarcinomaOvarian CarcinosarcomaUterine CarcinosarcomaUterine Serous CarcinomaEndometrium CancerChromosomal InstabilityKIF18A Inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-10-18
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05902988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * 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
  1. * MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
  2. * Previously received KIF18A inhibitor
  3. * Current CNS metastases or leptomeningeal disease
  4. * Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
  5. * 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
  6. * 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
  7. * Bowel obstruction or GI perforation within 6 months of planned first dose of study drug

Contacts and Locations

Study Contact

Volastra Therapeutics, Inc.
CONTACT
(646) 344-1248
clinicaltrials@volastratx.com

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06511
United States
Community Health Network
Indianapolis, Indiana, 46256
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21224
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The Christ Hospital
Cincinatti, Ohio, 45219
United States
Women & Infants Hospital
Providence, Rhode Island, 02905
United States
M.D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Volastra Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • KIF18A Inhibitor

Additional Relevant MeSH Terms

  • 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