ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aileron Therapeutics; Aileron Therapeutics, Inc.

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

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