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Phase I/II Study of VLS-1488 for Advanced Cancers

This study is testing a new oral drug called VLS-1488 for people with advanced solid tumors, including certain types of ovarian, lung, breast, and head and neck cancers. This is the first time VLS-1488 is being given to humans. The main goals are to find a safe dose, understand any side effects, and see if it shows early signs of working. You might be able to join if you are at least 18 years old, have a good performance status (meaning you can do most daily activities), and have measurable cancer that hasn't responded to other treatments. The study is currently not recruiting, as its status is unclear.

Study design
This is a Phase I/II study with two parts: Dose Escalation and Dose Expansion, planning to enroll 200 participants. It is an interventional study, meaning participants will receive the study drug.
What's involved
Participants will take VLS-1488 tablets orally in 28-day cycles. Dosing will continue until the disease worsens, side effects are too severe, or you decide to stop.
Compensation
Not stated in the trial record.
Follow-up
Safety and dose-related information will be measured for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05902988

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Volastra Therapeutics, Inc.
~200 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:VLS-1488

At a glance

Recruiting sites
13 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Measured over Up to 12 months
+7 more outcomes measured

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
Ovarian Carcinosarcoma
Uterine Carcinosarcoma
Uterine Serous Carcinoma
Endometrium Cancer
Chromosomal Instability

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NCT05902988

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Community Health Network

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Hoag Memorial Hospital

    Newport Beach, Californiastudy coordinator listed

    Recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • Kellogg Cancer Center

    Evanston, Illinoisstudy coordinator listed

    Recruiting

  • M.D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Volastra Therapeutics, Inc.
[email protected]
(646) 344-1248
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Dose Escalation: Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjectsUp to 12 months
  • Dose Escalation: Determination of the MTD of VLS-1488Up 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 5.0Up to 12 months
  • Dose Escalation: Frequency of Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0Up to 12 months
  • Dose Escalation: Frequency of Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0Up to 12 months
  • Dose Escalation: Frequency of Dose Interruptions and Permanent Treatment DiscontinuationsUp 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 1.1Up to 18 months