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

Launched by VOLASTRA THERAPEUTICS, INC. · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VLS-1488 for people with advanced cancers, including types like ovarian, lung, breast, and colorectal cancer. The goal is to find out how safe and effective this treatment is for patients who have not had good results from other therapies. The trial is currently looking for participants aged 18 and older who have measurable cancer that can be seen on scans. To be eligible, patients should also be in relatively good health and able to take medication by mouth.

Participants in the study can expect to receive VLS-1488 and will be closely monitored by researchers to see how their bodies respond. They will undergo regular tests to check for any side effects and to evaluate how well the treatment is working. It’s important to note that there are certain health conditions that could exclude someone from joining, such as recent heart problems or specific genetic markers related to their cancer. This trial represents a new opportunity for patients with advanced cancer who have limited treatment options.

Gender

ALL

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