Study Of ATRN-119 In Patients With Advanced Solid Tumors (ABOYA-119)
Status and phase
Active, not recruiting
Phase 2
Phase 1
Conditions
Advanced Solid Tumor
Treatments
Drug: ATRN-119
Details and patient eligibility
About
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.
Enrollment
132 estimated patients
Sex
All
Ages
12+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
132 participants in 12 patient groups
50mg ATRN-119
Experimental group
Description:
Once daily oral administration.
Treatment:
Drug: ATRN-119
100mg ATRN-119
Experimental group
Description:
Once daily oral administration.
Treatment:
Drug: ATRN-119
200mg ATRN-119
Experimental group
Description:
Once daily oral administration.
Treatment:
Drug: ATRN-119
350mg ATRN-119
Experimental group
Description:
Once daily oral administration.
Treatment:
Drug: ATRN-119
400mg ATRN-119
Experimental group
Description:
Twice daily oral administration.
Treatment:
Drug: ATRN-119
1100mg ATRN-119
Experimental group
Description:
Once daily oral administration
Treatment:
Drug: ATRN-119
1300mg ATRN-119
Experimental group
Description:
Once daily oral administration
Treatment:
Drug: ATRN-119
1500mg ATRN-119
Experimental group
Description:
Once daily oral administration
Treatment:
Drug: ATRN-119
650mg ATRN-119
Experimental group
Description:
Twice daily oral administration.
Treatment:
Drug: ATRN-119
750mg ATRN-119
Experimental group
Description:
Twice daily oral administration.
Treatment:
Drug: ATRN-119
550mg ATRN-119
Experimental group
Description:
Once or twice daily oral administration
Treatment:
Drug: ATRN-119
800 mg ATRN-119
Experimental group
Description:
Once daily oral administration
Treatment:
Drug: ATRN-119
Trial contacts and locations
7
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Central trial contact
Senior Medical Advisor
Data sourced from clinicaltrials.gov
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