Recruiting
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer
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.
ClinicalTrials.gov IDNCT05902988
PhasePHASE1, PHASE2
Enrollment200
SponsorVolastra Therapeutics, Inc.
Age18 Years
SexALL
Conditions studied
Advanced Solid Tumor, High Grade Serous Adenocarcinoma of Ovary, Squamous Non-small-cell Lung Cancer, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Ovarian Carcinosarcoma, Uterine Carcinosarcoma, Uterine Serous Carcinoma, Endometrium Cancer, Chromosomal Instability
About this study
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.
Interventions
- Drug: VLS-1488 — VLS-1488 tablets will be given orally.
Primary outcomes
- 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)
Eligibility information
Key Inclusion 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
Key Exclusion Criteria:
* 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
Study locations
- 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
Showing 10 of 14 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.