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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuPharma, Inc.

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