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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests VLS-1488 in adults with certain advanced cancers. It is the first study of this drug in people and will check its safety, side effects, and early signs that it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older and able to do most daily activities, with at most limits on hard physical activity.
  • You must have at least one cancer spot that can be measured on a CT or MRI scan.
  • You must be able to take medicine by mouth without changing its form.
  • For the part that tests increasing doses, you must have no treatment options left that are likely to give a meaningful benefit.
  • For the part that tests doses in larger groups, you must have already had several rounds of different standard treatments, as required by the study.
  • Both parts accept only certain cancer types: high-grade serous ovarian; squamous non-small cell lung; triple-negative breast; stomach adenocarcinoma without Epstein-Barr virus; colorectal; squamous cell cancer or adenocarcinoma of the esophagus (food pipe); certain head and neck squamous cell cancers; and CN-high uterine cancer, which has many changes in gene copy numbers.
  • Head and neck cancers cannot start in the upper throat behind the nose, nose or sinuses, or lip.
  • Only the increasing-dose part also accepts ovarian carcinosarcoma, transitional cell bladder cancer, and cancer where the food pipe meets the stomach.

Who can't join

  • Your cancer has certain genetic features: MSI-H, dMMR, a POLE hotspot mutation, or a known hypermutator pattern. These involve problems fixing DNA or unusually many DNA changes.
  • You have already received a KIF18A inhibitor, a drug that blocks the KIF18A protein.
  • You currently have cancer that has spread to the brain, spinal cord, or their lining.
  • You had a heart attack or stroke within 1 year; or unstable chest pain, a lung blood clot, a deep vein blood clot, or heart bypass surgery within 6 months.
  • You have heart failure that limits ordinary activity or worse, or your heart pumps out less than 50% of the blood in its main pumping chamber.
  • You cannot follow limits on certain other medicines that affect how the body handles drugs, including CYP3A, MDR1 (P-gp), and BCRP.
  • You have a medically important buildup of fluid in your belly or around your lungs when you join, or had fluid drained from either area for treatment within 28 days before the planned first dose.
  • You had a blocked bowel or a hole in your stomach or intestines within 6 months before the planned first dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (14)

CA

CO

CT

IL

IN

MD

MI

NY

OH

RI

TX

WI