Clinical trial · Interventional
Study Of ATRN-119 In Patients With Advanced Solid Tumors
A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
NCT04905914CI-TRIAL-00120489ABOYA-119completedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid tumors.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATRN-119 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- 50mg ATRN-119
- description
- Once daily oral administration.
- interventionNames
- Drug: ATRN-119
- type
- EXPERIMENTAL
- label
- 100mg ATRN-119
- description
- Once daily oral administration.
- interventionNames
- Drug: ATRN-119
- type
- EXPERIMENTAL
- label
- 200mg ATRN-119
- description
- Once daily oral administration.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period. * Measurable disease defined by RECIST 1.1. * Life expectancy ≥ 3 months. * Subject must be capable of oral administration of study medication. Exclusion Criteria: * Patient has had a cytotoxic chemotherapy, immunotherapy, radiotherapy or other targeted therapies within 4 weeks. * Surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. * Concomitant treatment with strong inhibitors or inducers of CYP3A4 and CYP2D6. * Known human immunodeficiency virus infection (HIV). * Subjects with active viral or bacterial infections and/or receiving systemic antibiotics or anti-viral medications. * Current or past diagnosis of leukemia within the past 5 years. * Prior radiotherapy at the target lesion unless there is evidence of disease progression. * Known CNS metastases or clinical evidence of CNS involvement that is not stable for previous 1 month by radiology documentation (magnetic resonance imaging \[MRI\] brain). * History of non-malignant gastronintestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months. * Patient has uncontrolled hypertension at time of enrollment. * Complete left bundle branch block (LBBB), bifascicular block (right bundle branch block \[RBBB\] with either left anterior hemiblock or left posterior hemiblock). * Any clinically significant ST segment and/or T-wave abnormalities. * Myocardial infarction or unstable angina pectoris within 6 months prior to starting study medication.
References
Publications (0)
Data not yet available
No reference posted for this study.