Clinical trial · Interventional
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1/2a Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone or in Combination in Patients With Advanced Solid Tumors or Lymphomas Expressing Wild-Type p53 Protein
NCT02264613CI-TRIAL-00100746completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALRN-6924 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Regimen A (DR-A)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle.
- interventionNames
- Drug: ALRN-6924
- type
- EXPERIMENTAL
- label
- Dose Regimen B (DR-B)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 4, 8 and 11 of a 21-day cycle
- interventionNames
- Drug: ALRN-6924
- type
- EXPERIMENTAL
- label
- Dose Regimen C (DR-C)
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhou 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 34230007