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New drug shows promise for Hard-to-Treat cancers with p53 gene

NCT ID NCT02264613

Disease control Sponsor: Aileron Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new drug called ALRN-6924 in 142 people with advanced solid tumors or lymphomas that have a normal p53 gene. The goal was to see if the drug is safe and can shrink tumors. Participants had cancers that did not respond to standard treatments or had no standard options.

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

142 people

The number who actually took part.

Started

Oct 2014

Finished

Apr 2020

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

18 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 * Histologically or cytologically confirmed solid tumor or lymphoma that is not amenable to standard therapies. * Cohort specific biomarkers, including confirmed or anticipated WT TP53 (Phase 1 and PTCL expansion cohorts) and MDM2-amplification or MDM2/CDK4-co-amplification (solid tumor expansion cohort) * At least one target lesion that is measurable by RECIST 1.1, RANO or IWG 2014, as appropriate for tumor type * ECOG (Eastern Cooperative Oncology Group) performance status 0-1 * Adequate coagulation and hematologic function * Adequate hepatic and renal function * Sufficient wash out from prior therapies and recovery from all significant acute toxicities Key Exclusion Criteria * Prior treatment with an MDM2 inhibitor, with protocol specified exceptions * Known hypersensitivity to any study drug component * Protocol specified cardiovascular risk factors * Clinically significant gastrointestinal bleeding within 6 months * Clinically significant third-space fluid accumulation * Active uncontrolled infection, including HIV/AIDS or Hepatitis B or C * HPV positive tumors * Second malignancy within two years, with protocol specified exceptions * Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma Peripheral T-cell lymphoma Solid tumor

Contacts and locations

Locations

  • Study site

    Birmingham, Alabama, 35294, United States

  • Study site

    Duarte, California, 91010, United States

  • Study site

    Denver, Colorado, 80218, United States

  • Study site

    Sarasota, Florida, 34232, United States

  • Study site

    Tampa, Florida, 33612, United States

  • Study site

    Boston, Massachusetts, 02114, United States

  • Study site

    Boston, Massachusetts, 02215, United States

  • Study site

    New York, New York, 10065, United States

  • Study site

    The Bronx, New York, 10461, United States

  • Study site

    Greenville, South Carolina, 29605, United States

  • Study site

    Nashville, Tennessee, 37203, United States

  • Study site

    Houston, Texas, 77030, United States

  • Study site

    Seattle, Washington, 98105, United States

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