New pill targets tough cancers in early human trial
NCT ID NCT04905914
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This early-phase trial is testing an oral drug called ATRN-119 in 132 people with advanced solid tumors that have specific DNA repair mutations. The main goals are to check safety, how the drug moves through the body, and whether it can shrink tumors. Participants must be able to take pills by mouth and have a life expectancy of at least 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATRN-119 (oral capsule)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have specific DNA repair mutations.
- What could go wrong
- This is an early-phase trial (Phase 1/2a) with only 132 participants, so it is too small to prove effectiveness. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
43 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
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Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Jordan Center for Gynecologic Oncology at Penn Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
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Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
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NEXT Oncology- San Antonio
San Antonio, Texas, 78229, United States
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NEXT Oncology- Virginia
Fairfax, Virginia, 22031, United States
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NEXT- Oncology Dallas
Irving, Texas, 75039, United States
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University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors