NCT05976334

An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors

A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat. The study consists of two parts. In Part A, participants will receive a single infusion of C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for up to 1 year.

Detailed description

The drug being tested in this study is called \[14C\]subasumstat. \[14C\]Subasumstat is being tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of people who have advanced or metastatic solid tumors. The study will enroll approximately 10 patients. Participants will be enrolled to receive a single dose of \[14C\]subasumstat: \- \[14C\]Subasumstat 90 mg Participants will be administered with a single dose of \[14C\]subasumstat 90 mg as a 1-hour intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14 days postdose. Participants will then have an option to enter Part B of the study to receive non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle for 3 cycles up to maximum treatment duration of 1 year. This multi-center trial will be conducted in Hungary. The overall study duration is 12 months for Part A and 24 months for Part B.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	[14C] Subasumstat	\[14C\] Subasumstat IV infusion.
DRUG	Subasumstat	Subasumstat IV infusion.

Timeline

• Start date: 2023-11-14
• Primary completion: 2024-06-21
• Completion: 2024-07-16
• First posted: 2023-08-04
• Last updated: 2025-10-06
• Results posted: 2025-10-06

Locations

2 sites across 1 country: Hungary