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New pill targets tough cancers in early human trial

NCT ID NCT04905914

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • NEXT Oncology- San Antonio

    San Antonio, Texas, 78229, United States

  • NEXT Oncology- Virginia

    Fairfax, Virginia, 22031, United States

  • NEXT- Oncology Dallas

    Irving, Texas, 75039, United States

  • University Hospitals, Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028, United States

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