Help the Future of Cancer Treatment

Volunteering for a clinical trial is a contribution to the future of medicine that only you can make.

A phase I/II study of VLS-1488 (an oral KIF18A inhibitor) in subjects with advanced cancer

Primary Investigator
Swiecicki, Paul
Status
OPEN TO ACCRUAL
Phase
I
II
NCT Number
NCT05902988
UM Number
2023.078
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Multi-tumor Experimental Therapeutics
ID (Protocol)
47035
Secondary Protocol No
HUM00240444
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Breast
Colon
Esophagus
Larynx
Lung
Other Female Genital
Ovary
Rectum
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.

Eligibility: Inclusion 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