Clinical trial · Interventional
A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]-Nanatinostat | Drug | — | UNRESOLVED |
| Nanatinostat (free base) tablets in combination with Valganciclovir | Drug | — | UNRESOLVED |
| Nanatinostat mesylate tablets in combination with Valganciclovir | Drug | — | UNRESOLVED |
| Single-agent Nanatinostat (free base) tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part A: [14C]-Nanatinostat
- interventionNames
- Drug: [14C]-Nanatinostat
- type
- EXPERIMENTAL
- label
- Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir
- description
- Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.
- interventionNames
- Drug: Nanatinostat (free base) tablets in combination with Valganciclovir
- type
- EXPERIMENTAL
- label
- Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir
- description
- Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available