Recruiting

Phase 1

Phase 2

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

Sponsor:

Volastra Therapeutics, Inc.

Code:

NCT05902988

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VLS-1488

Study Details

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.

Conditions

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

Study ID

NCT05902988

Start date

Oct 18, 2023

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation: Dose Escalation Cohorts

Subjects 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.

experimental: Dose Escalation: Backfill Cohorts

Additional 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.

experimental: Dose Expansion: Exploration Cohorts

Subjects 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.

experimental: Dose Expansion: Development Cohorts

Subjects 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

VLS-1488 tablets will be given orally.

Primary outcome measure

Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects [ Time Frame: Up to 12 months ]
Dose Escalation: Determination of the MTD of VLS-1488 [ Time Frame: 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 [ Time Frame: Up to 12 months ]
Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0 [ Time Frame: Up to 12 months ]
Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0 [ Time Frame: Up to 12 months ]
Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment Discontinuations [ Time Frame: Up to 12 months ]
Dose Expansion: Frequency of Trigger Events (TEs) [ Time Frame: Up to 18 months ]
Dose Expansion: Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Volastra Therapeutics, Inc.

(646) 344-1248 clinicaltrials@volastratx.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Xiomara Menendez, RN

Xiomara.Menendez@med.usc.edu

Lorraine Martinez, MD

Lorraine.Martinez@med.usc.edu

Hoag Memorial Hospital

Recruiting

Newport Beach, California, United States, 92663

Contacts

Patrice Jones

9497645501 patrice.jones@hoag.org

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Yasmin Yazdani Farsad

303-724-9403 YASMIN.YAZDANIFARSAD@CUANSCHUTZ.EDU

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Ingrid Palma

203-833-1034 ingrid.palma@yale.edu

Kellogg Cancer Center

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Michele Britto

(847) 570-2109 mbritto@northshore.org

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Megan Haas

mhaas2@ecommunity.com

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Matthew Bark

443-927-8743 Mbark1@jhmi.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer AnswerLine

800-865-1125 CancerAnswerLine@med.umich.edu

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Claire Friedman, MD

646-888-4593 friedmac@mskcc.org

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Abby Reed, RN

513-585-1140 abby.reed@thechristhospital.com

Women & Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Emma Locke

401-430-8181 oncologyresearch@wihri.org

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ecaterina Dumbrava, MD

713-792-3934 eeileana@mdanderson.org

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Clinical Trials Office

414-805-8900 cccto@mcw.edu

More Information

Sponsor

Volastra Therapeutics, Inc.

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Keywords

KIF18A Inhibitor
HGSOC
TNBC
HNSCC
sqNSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Volastra Therapeutics, Inc. on 2025-11-04.