NCT03646071

A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: NeuPharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in patients with locally advanced or metastatic solid tumors.

Detailed description

This is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety, pharmacokinetics, and efficacy of RX108 at the RP2D.

Conditions

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	RX108	RX108

Timeline

• Start date: 2018-08-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2018-08-24
• Last updated: 2022-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study