A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers

Viracta Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: Nanatinostat (free base) tablets in combination with Valganciclovir; Drug: [14C]-Nanatinostat; Drug: Nanatinostat mesylate tablets in combination with Valganciclovir; Drug: Single-agent Nanatinostat (free base) tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06302140

VT3996-102

Details and patient eligibility

About

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.

Full description

This is a Phase 1, open-label, 3-part study evaluating the mass balance, pharmacokinetics, and metabolism of nanatinostat following a single oral dose of [14C]-nanatinostat for Part A, evaluating relative bioavailability of nanatinostat mesylate and nanatinostat (free base) tablets after coadministration with valganciclovir in patients with advanced stage cancers for Part B, and evaluating the safety and antitumor activity of nanatinostat for Part C.

The study was terminated prematurely and did not reach its target enrollment.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

Part A: [14C]-Nanatinostat

Experimental group

Treatment:

Drug: [14C]-Nanatinostat

Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir

Experimental group

Description:

Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.

Treatment:

Drug: Nanatinostat (free base) tablets in combination with Valganciclovir

Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir

Experimental group

Description:

Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.

Treatment:

Drug: Nanatinostat mesylate tablets in combination with Valganciclovir

Part C: Single-agent Nanatinostat (free base) tablets

Experimental group

Treatment:

Drug: Single-agent Nanatinostat (free base) tablets