ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma

In brief

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

Key facts

Study ID

NCT02264613

Run by

Aileron Therapeutics, Inc.

People needed

142

Starts

2014-10-01

Expected to finish

2020-04-01

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Duarte, California, United States
• Study site — Denver, Colorado, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Greenville, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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