A Phase 1 Study to Investigate the Mass Balance of [14C]-Nanatinostat and to Evaluate the Relative Bioavailability of Nanatinostat in Patients With Selected Advanced Cancers

VT3996-102

This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers.

2024-02-28

2025-02-01

2025-10-01

Recruiting

Early phase I

14

Key Inclusion Criteria: * Have histologically confirmed advanced stage cancers (excluding gastrointestinal tumors), have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment, and have no available treatment with curative intent. * Eastern Cooperative Oncology Group Performance Status of ≤2 at Screening. * Body mass index ≥18.5 but ≤30.0 kg/m2 at Screening. * Adequate bone marrow, liver, and kidney function. Key Exclusion Criteria: * Presence of active central nervous system and/or leptomeningeal disease. * Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or use of other investigational agents within 4 weeks before study entry. * Inability to take or tolerate oral medication. * Any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. * Active infection requiring systemic therapy. * Has received radiolabeled material \<12 months (excluding that required for imaging) prior to study entry.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This clinical trial is divided into 3 parts (Part A, Part B, and Part C).\n\nPatients may begin their study participation in Part A or Part B. Part B (for patients who participate in Part A) and Part C (for patients who participate in Part A and/or Part B) are optional for patients who meet certain conditions for crossover.\n\nIn Part A, patients will be given a single dose of radiolabeled nanatinostat by mouth on Day 1. Patients may stay in the hospital up to 8 days.\n\nIn Part B, patients will receive both nanatinostat in a salt form and a non-salt form, coadministered with valganciclovir in different order across 2 treatment days. Patients will be randomly assigned to either receive the salt or the non-salt form of nanatinostat first. Patients may stay in the hospital up to 4 days.\n\nPart C will allow patients to continue receiving nanatinostat treatment as long as they are deriving clinical benefit. This part will not require a hospital stay.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ESTIMATED'}}

2024-03-29