Phase 2 N=142 Treatment

ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas

Solid Tumor · Lymphoma · Peripheral T-Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT02264613 ↗

Enrolled (actual)

142

Serious AEs

19.0%

Results posted

Jan 2026

Primary outcome: Primary: 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 — 5; 3; 4; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ALRN-6924 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aileron Therapeutics, Inc.
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	5; 3; 4; 3; 6; 9	—
PRIMARY 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	21; 16; 34	—
PRIMARY Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas	3.1; NA	—
PRIMARY Determine Overall Response Rate	2; 2	—
SECONDARY Assess Additional Measures of Anti-tumor Activity, Including Duration of Response, Progression Free Survival, Overall Survival and Time to Response	0; 0; 0; 0; 1; 0	—
SECONDARY Determine Pharmacokinetic Parameters of ALRN-6924 When Administered to Patients With Advanced Solid Tumors or Lymphomas	0.03; 0.13; 0.04; 0.04; 0.29; 0.12	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02264613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.