Recruiting
Phase 1

RX108

Sponsor:

NeuPharma, Inc.

Code:

NCT03646071

Conditions

Locally Advanced Solid Tumors

Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RX108

Study Details

Brief 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.

Conditions

Locally Advanced Solid Tumors

Metastatic Solid Tumors

Study ID

NCT03646071

Start date

Aug 1, 2018

Status verified date

Apr, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Phase

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

experimental: Dose Expansion Phase

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

Interventions

RX108

RX108

Primary outcome measure

  • Part 1: Maximum tolerated dose (MTD) of RX108 [ Time Frame: Day 1 to 30 ]
  • Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Day 1 to 30 days post last dose ]

Central Contacts and Locations

Central contacts

Lyon Gleich, MD

(513) 579-9911l.gleich@medpace.com

Locations

Cedars-Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Vanessa Cajahuaringa

310-967-2795vanessa.cajahuaringa@cshs.org

Principal Investigator:

Monica Mita, MD

University of Texas at MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lidong Liu, PhD

lliu8@mdanderson.org

Principal Investigator:

Siqing Fu, MD

More Information

Sponsor

NeuPharma, Inc.

Last update posted

Apr 13, 2022

Last verified

Apr, 2022

Keywords

  • Locally Advanced
  • Metastatic
  • Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NeuPharma, Inc. on 2022-04-13.