NCT02264613

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

Completed Phase 1/Phase 2 Results posted Last updated 9 January 2026

What this trial tests

Phase 1/Phase 2 trial testing ALRN-6924 in Solid Tumor in 142 participants. Completed in 1 April 2020.

Timeline

1 October 2014

Primary endpoint
1 March 2020

1 April 2020

Quick facts

Lead sponsor	Aileron Therapeutics, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	142
Start date	1 October 2014
Primary completion	1 March 2020
Estimated completion	1 April 2020
Sites	13 locations across United States

Drugs / interventions tested

• ALRN-6924 — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →
• Lymphoma — all drugs for Lymphoma →
• Peripheral T-Cell Lymphoma — all drugs for Peripheral T-Cell Lymphoma →

Sponsor

Aileron Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
  Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
• 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
  Time frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
  Number of participants with treatment-related adverse events as assessed by CTCAE v.4.0
• Determine the Maximum Tolerated Dose (MTD) of ALRN-6924 in Adult Patients With Advanced Solid Tumors or Lymphomas
  Time frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
  Determine the maximum tolerated dose (MTD)
• Determine Overall Response Rate
  Time frame: From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
  The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting p53 pathways: mechanisms, structures, and advances in therapy.
   Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
2. Recent advances in the development of protein-protein interactions modulators: mechanisms and clinical trials.
   Lu H, Zhou Q, He J, Jiang Z, et al · · 2020 · cited 570× · PMID 32968059 · DOI 10.1038/s41392-020-00315-3
3. Targeting mutant p53 for cancer therapy: direct and indirect strategies.
   Hu J, Cao J, Topatana W, Juengpanich S, et al · · 2021 · cited 379× · PMID 34583722 · DOI 10.1186/s13045-021-01169-0
4. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
   Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
5. Clinical Overview of MDM2/X-Targeted Therapies.
   Burgess A, Chia KM, Haupt S, Thomas D, et al · · 2016 · cited 242× · PMID 26858935 · DOI 10.3389/fonc.2016.00007
6. The Role of p53 Signaling in Colorectal Cancer.
   Liebl MC, Hofmann TG. · · 2021 · cited 231× · PMID 33924934 · DOI 10.3390/cancers13092125
7. Dual inhibition of MDMX and MDM2 as a therapeutic strategy in leukemia.
   Carvajal LA, Neriah DB, Senecal A, Benard L, et al · · 2018 · cited 197× · PMID 29643228 · DOI 10.1126/scitranslmed.aao3003
8. MDM2/X inhibitors under clinical evaluation: perspectives for the management of hematological malignancies and pediatric cancer.
   Tisato V, Voltan R, Gonelli A, Secchiero P, et al · · 2017 · cited 191× · PMID 28673313 · DOI 10.1186/s13045-017-0500-5