Advanced Solid TumorPhase 1/2ABOYA-119NCT04905914
Study Of ATRN-119 In Patients With Advanced Solid Tumors
A Phase 1/2 study testing ATRN-119 in people with Advanced Solid Tumor, run by Aprea Therapeutics at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ATRN-119
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Jan 2023to 9 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Mary Crowley Cancer Research
Dallas, Texas, 75230
NEXT Oncology- Virginia
Fairfax, Virginia, 22031
NEXT- Oncology Dallas
Irving, Texas, 75039
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
NEXT Oncology- San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
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
- Advanced Solid Tumor
- Being tested
- ATRN-119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATRN-119Drug
ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
| Study group | Role | What they receive |
|---|---|---|
| 50mg ATRN-119 | Experimental | Once daily oral administration. Receives: Drug: ATRN-119 |
| 100mg ATRN-119 | Experimental | Once daily oral administration. Receives: Drug: ATRN-119 |
| 200mg ATRN-119 | Experimental | Once daily oral administration. Receives: Drug: ATRN-119 |
| 350mg ATRN-119 | Experimental | Once daily oral administration. Receives: Drug: ATRN-119 |
| 400mg ATRN-119 | Experimental | Twice daily oral administration. Receives: Drug: ATRN-119 |
| 1100mg ATRN-119 | Experimental | Once daily oral administration Receives: Drug: ATRN-119 |
| 1300mg ATRN-119 | Experimental | Once daily oral administration Receives: Drug: ATRN-119 |
| 1500mg ATRN-119 | Experimental | Once daily oral administration Receives: Drug: ATRN-119 |
| 650mg ATRN-119 | Experimental | Twice daily oral administration. Receives: Drug: ATRN-119 |
| 750mg ATRN-119 | Experimental | Twice daily oral administration. Receives: Drug: ATRN-119 |
| 550mg ATRN-119 | Experimental | Once or twice daily oral administration Receives: Drug: ATRN-119 |
| 800 mg ATRN-119 | Experimental | Once daily oral administration Receives: Drug: ATRN-119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start9 Jan 2023
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 Dose escalation design
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aprea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Crystal Miller, RN BSN, Study director, Aprea Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905914
- Sponsor's protocol ID
- AR-276-01
- Acronym
- ABOYA-119
- Status last verified
- Aug 2026
- First submitted
- 17 May 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label, Safety, Pharmacokinetic, And Preliminary Efficacy Study Of Oral ATRN-119 In Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04905914
- Acronym / sponsor ID
- ABOYA-119 / AR-276-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aprea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- 3+3 Dose escalation design
| Arm | Type | Receives |
|---|---|---|
| 50mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration. |
| 100mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration. |
| 200mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration. |
| 350mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration. |
| 400mg ATRN-119 | Experimental | Drug: ATRN-119Twice daily oral administration. |
| 1100mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration |
| 1300mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration |
| 1500mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration |
| 650mg ATRN-119 | Experimental | Drug: ATRN-119Twice daily oral administration. |
| 750mg ATRN-119 | Experimental | Drug: ATRN-119Twice daily oral administration. |
| 550mg ATRN-119 | Experimental | Drug: ATRN-119Once or twice daily oral administration |
| 800 mg ATRN-119 | Experimental | Drug: ATRN-119Once daily oral administration |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATRN-119ATRN-119 is a capsule formulation that will be supplied as 50 mg and 100 mg capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose. | Drug | 100mg ATRN-119, 1100mg ATRN-119, 1300mg ATRN-119, 1500mg ATRN-119, 200mg ATRN-119, 350mg ATRN-119, 400mg ATRN-119, 50mg ATRN-119, 550mg ATRN-119, 650mg ATRN-119, 750mg ATRN-119, 800 mg ATRN-119 |
Primary outcome
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics
Time frame: Day 1 to Day 28
Treatment-emergent AEs (TEAEs) will be collected and Clinical Laboratory Evaluations will be performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Miller, RN BSN study director
Aprea Therapeutics Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATRN-119 in people with Advanced Solid Tumor, run by Aprea Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.