NCT02264613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

October 7, 2014

Results QC Date

December 2, 2024

Last Update Submit

January 9, 2026

Conditions

Solid TumorLymphomaPeripheral T-Cell Lymphoma

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    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 Outcomes (2)

  • Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response

    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

    8 weeks

Study Arms (4)

Dose Regimen A (DR-A)

EXPERIMENTAL

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

Drug: ALRN-6924

Dose Regimen B (DR-B)

EXPERIMENTAL

Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle

Drug: ALRN-6924

Dose Regimen C (DR-C)

EXPERIMENTAL

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

Drug: ALRN-6924

Combination with palbociclib

EXPERIMENTAL

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

Interventions

ALRN-6924DRUG

ALRN-6924 will be administered as an IV infusion

Combination with palbociclibDose Regimen A (DR-A)Dose Regimen B (DR-B)Dose Regimen C (DR-C)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Duarte, California, 91010, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

The Bronx, New York, 10461, United States

Location

Unknown Facility

Greenville, South Carolina, 29605, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • 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.

    PMID: 34230007DERIVED

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Results Point of Contact

Title
Allen Annis
Organization
Consultant
aannis@aileronrx.com
617-921-9467

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

January 13, 2026

Results First Posted

January 13, 2026

Record last verified: 2026-01

Locations

US(13)