Trial | NCT03646071  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    RX108

  • Study Participants

    80
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.
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.
Study Started
Aug 01
2018
Primary Completion
Aug 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Apr 13
2022

Drug RX108

RX108

Dose Escalation Phase Experimental

The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.

Dose Expansion Phase Experimental

In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.

Criteria 

Inclusion Criteria:

Histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age of 18 years
Adequate hematologic, hepatic and renal function
Written Informed Consent
Must agree to use adequate contraception (females and males)

Exclusion Criteria:

History of certain cardiac abnormalities
History of inadequate pulmonary function
Symptomatic brain metastasis
Treatment with prohibited medications
Known contra-indication to digoxin
Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia
Clinically significant active infection requiring systemic antibiotic treatment
Females who are pregnant or breastfeeding
No Results Posted