Clinical trial · Interventional
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
NCT03646071CI-TRIAL-00057766unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RX108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Phase
- description
- The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.
- interventionNames
- Drug: RX108
- type
- EXPERIMENTAL
- label
- Dose Expansion Phase
- description
- In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
- interventionNames
- Drug: RX108
Primary outcomes (2)
- measure
- Part 1: Maximum tolerated dose (MTD) of RX108
- timeFrame
- Day 1 to 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.