ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

January 9, 2026 updated by: Aileron Therapeutics, Inc.

A Phase 1/2a Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone or in Combination in Patients With Advanced Solid Tumors or Lymphomas Expressing Wild-Type p53 Protein

This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Open label, multi center, Phase 1 (dose escalation) and Phase 2a (dose expansion) study design to evaluate safety, tolerability, PK, PD and anti-tumor effects of ALRN-6924, alone or in combination with palbociclib, in patients with advanced solid tumors or lymphomas with wild-type (WT) TP53. ALRN-6924 is a stabilized cell-permeating peptide designed to disrupt the interaction between the p53 tumor suppressor protein and its predominant endogenous inhibitors, murine double minute 2 (MDM2) and murine double minute X (MDMX).

The Phase 1 portion of the study will enroll adults with histologically or cytologically confirmed malignancies that are metastatic or unresectable and for which standard treatment(s) are not available or are no longer effective. The Phase 2a portion of the study consists of separate cohorts that will enroll distinct groups of patients with specific solid tumors and/or lymphomas to further investigate the clinical safety profile and potential efficacy of ALRN-6924 alone or in a combination regimen.

Treatment will continue until unacceptable toxicity, patient or physician decision to discontinue therapy or disease progression that is either symptomatic, rapidly progressive, requires urgent intervention or is associated with a decline in performance status.

Patients with PTCL have been selected as a group to be further studied in Phase 2a.

Patients with MDM2-amplified or MDM2/CDK4-co-amplified solid tumors have been selected as another group to be further studied in Phase 2a.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Duarte, California, United States, 91010
    • Colorado
      • Denver, Colorado, United States, 80218
    • Florida
      • Sarasota, Florida, United States, 34232
      • Tampa, Florida, United States, 33612
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02114
    • New York
      • New York, New York, United States, 10065
      • The Bronx, New York, United States, 10461
    • South Carolina
      • Greenville, South Carolina, United States, 29605
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Regimen A (DR-A)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion
Experimental: Dose Regimen B (DR-B)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion
Experimental: Dose Regimen C (DR-C)
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion
Experimental: Combination with palbociclib
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle Drug: Palbociclib Fixed-dose capsule administered orally on days 1 through 21 of a 28-day cycle
Drug: ALRN-6924
ALRN-6924 will be administered as an IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists
Time Frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Evaluate the Safety and Tolerability of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas With Wild-type (WT) TP53 Who Are Refractory to or Intolerant of Standard Therapy, or for Whom no Standard Therapy Exists, Expansion
Time Frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas
Time Frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Determine the maximum tolerated dose (MTD)
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Determine Overall Response Rate
Time Frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response
Time Frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas
Time Frame: 8 weeks
Time of Peak Plasma Concentration (Tmax)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aileron Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimated)

October 15, 2014

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALRN-6924-1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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