Clinical trial · Interventional
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
NCT06533332CI-TRIAL-00112940recruitingPhase 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)
This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERX-315 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ERX-315
- description
- Active investigational therapy
- interventionNames
- Drug: ERX-315
Primary outcomes (4)
- measure
- Incidence of Dose Limiting Toxicities of ERX-315
- timeFrame
- 21 days
- description
- First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
- measure
- Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
- timeFrame
- 84 days
- description
- Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be at least 18 years of age at the time of signing the informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective * Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Adequate baseline organ function and hematologic function * Life expectancy \>3 months Exclusion Criteria: * Systemic anti cancer therapy within 4 weeks of first dose of study drug * Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug. * Uncontrolled intercurrent illnesses * Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.
References
Publications (0)
Data not yet available
No reference posted for this study.