ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

NCT ID: NCT02264613

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2020-04-30

Brief Summary

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

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.

Conditions

Solid Tumor; Lymphoma; Peripheral T-Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Regimen A (DR-A)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.

Group Type: EXPERIMENTAL

ALRN-6924

Intervention Type: DRUG

ALRN-6924 will be administered as an IV infusion

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

Group Type: EXPERIMENTAL

ALRN-6924

Intervention Type: DRUG

ALRN-6924 will be administered as an IV infusion

Dose Regimen C (DR-C)

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle

Group Type: EXPERIMENTAL

ALRN-6924

Intervention Type: DRUG

ALRN-6924 will be administered as an IV infusion

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

Group Type: EXPERIMENTAL

ALRN-6924

Intervention Type: DRUG

ALRN-6924 will be administered as an IV infusion

Interventions

ALRN-6924

ALRN-6924 will be administered as an IV infusion

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aileron Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Duarte, California, United States

Denver, Colorado, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

New York, New York, United States

The Bronx, New York, United States

Greenville, South Carolina, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Seattle, Washington, United States

Countries

United States

References

Zhou X, Singh M, Sanz Santos G, Guerlavais V, Carvajal LA, Aivado M, Zhan Y, Oliveira MMS, Westerberg LS, Annis DA, Johnsen JI, Selivanova G. Pharmacologic Activation of p53 Triggers Viral Mimicry Response Thereby Abolishing Tumor Immune Evasion and Promoting Antitumor Immunity. Cancer Discov. 2021 Dec 1;11(12):3090-3105. doi: 10.1158/2159-8290.CD-20-1741.

Reference Type: DERIVED

PMID: 34230007 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ALRN-6924-1-01

Identifier Type: -

Identifier Source: org_study_id