A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
1 other identifier
interventional
200
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2023
Typical duration for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 4, 2025
October 1, 2025
2.6 years
May 31, 2023
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Up to 12 months
Dose Escalation: Determination of the MTD of VLS-1488
Up to 12 months
Dose Escalation: Frequency of Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Up to 12 months
Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Up to 12 months
Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
Up to 12 months
Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Up to 12 months
Dose Expansion: Frequency of Trigger Events (TEs)
Up to 18 months
Dose Expansion: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Up to 18 months
Secondary Outcomes (19)
Dose Escalation: ORR as assessed by RECIST version 1.1
Up to 12 months
Dose Expansion: Frequency of SAEs graded according to NCI-CTCAE version 5.0
Up to 18 months
Dose Expansion: Frequency of Treatment-related AEs graded according to NCI-CTCAE version 5.0
Up to 18 months
Dose Expansion: Frequency of TEAEs graded according to NCI-CTCAE version 5.0
Up to 18 months
Dose Expansion: Frequency of Dose Interruptions and Permanent Treatment Discontinuations
Up to 18 months
- +14 more secondary outcomes
Study Arms (4)
Dose Escalation: Dose Escalation Cohorts
EXPERIMENTALSubjects will be enrolled at various doses and/or schedules of VLS-1488. These Dose Escalation Cohorts will be utilized to identify the MTD and to select dose levels for Dose Expansion.
Dose Escalation: Backfill Cohorts
EXPERIMENTALAdditional subjects may be enrolled at any dose level that does not meet de-escalation or elimination rules per the BOIN design. These Backfill Cohorts will be utilized to build additional data to support selection of doses and/or tumor types for further study in Dose Expansion.
Dose Expansion: Exploration Cohorts
EXPERIMENTALSubjects with a selected single tumor type will be randomized 1:1 into Exploration Cohorts at two or more dose levels of interest. A subset of subjects will have additional assessments to examine the potential for VLS-1488 to interact with other drugs and the effect of food on VLS-1488 absorption.
Dose Expansion: Development Cohorts
EXPERIMENTALSubjects with other tumor types will be enrolled at a single dose level of interest. These Development Cohorts will be utilized to examine the preliminary efficacy of VLS-1488 in various tumor types.
Interventions
VLS-1488 tablets will be given orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Southern California
Los Angeles, California, 90033, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06511, United States
Kellogg Cancer Center
Evanston, Illinois, 60201, 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
Cincinnati, Ohio, 45219, United States
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 15, 2023
Study Start
October 18, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 4, 2025
Record last verified: 2025-10