Clinical trial · Interventional
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies
- 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)
The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).
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 |
|---|---|---|---|
| Metastatic Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RX-3117 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RX-3117
- description
- All subjects will receive RX-3117.
- interventionNames
- Drug: RX-3117
Primary outcomes (5)
- measure
- Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1
- timeFrame
- 28 days
- description
- Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)
- measure
- Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1
- timeFrame
- through study completion, up to 224 days (8 cycles of treatment)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females who are 18 years or older * Able to swallow capsules * Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer * Able to discontinue all anticancer therapies 2 weeks prior to study start * Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors * Life expectancy of at least 3 months * ECOG performance status of 0 or 1 * Provide written informed consent Exclusion Criteria: * Primary brain tumors or clinical evidence of active brain metastasis * Systemic corticosteroid use within 7 days before planned start of study therapy * Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy * Uncontrolled diabetes as assessed by the investigator * Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus * History of bone marrow of solid organ transplantation * History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes * Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results * Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside * Pregnant, planning a pregnancy or breast feeding during the study * Concurrent participation in another therapeutic clinical trial
References
Publications (0)
Data not yet available