ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

Status: Active

Description

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

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

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Dayle Craig
Phone: 205-975-8080
Email: dc0350@uab.edu

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Boston Children's Hospital
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Contact: Brian Owen Beardslee
Phone: 617-632-5638
Email: brian_beardslee@dfci.harvard.edu

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Funda Meric-Bernstam
Phone: 713-792-3245
Email: fmeric@mdanderson.org

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Aileron Therapeutics

Trial IDs

Primary ID ALRN-6924-1-01
Secondary IDs NCI-2015-00008, ALRN-200-01
Clinicaltrials.gov ID NCT02264613