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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Locally Advanced Solid Tumors Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Phase

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

Group Type EXPERIMENTAL

RX108

Intervention Type DRUG

RX108

Dose Expansion Phase

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

Group Type EXPERIMENTAL

RX108

Intervention Type DRUG

RX108

Interventions

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RX108

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No