Brief Title: VLS-1488 in Subjects With Advanced Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Advanced Solid Tumor
• High Grade Serous Adenocarcinoma of Ovary
• Squamous Non-small-cell Lung Cancer
• Triple Negative Breast Cancer
• Gastric Adenocarcinoma
• Colorectal Adenocarcinoma
• Esophageal Squamous Cell Carcinoma
• Esophageal Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Transitional Cell Carcinoma of Bladder
• Head and Neck Squamous Cell Carcinoma
• Ovarian Carcinosarcoma
• Uterine Carcinosarcoma
• Uterine Serous Carcinoma
• Endometrium Cancer
• Chromosomal Instability

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Volastra Therapeutics, Inc.

Phone: (646) 344-1248

Email: clinicaltrials@volastratx.com

LOCATION