NEW YORK – Aileron Therapeutics said on Thursday it has begun a Phase Ib study of its chemoprotective therapy, ALRN-6924, in patients with p53-mutated non-small cell lung cancer.
The randomized, double-blind study will include 60 patients who will receive carboplatin or pemetrexed with either ALRN-6924 or a placebo. Researchers are interested in whether ALRN-6924 can protect healthy cells and reduce toxicity from chemotherapy.
The trial's primary endpoint is the proportion of treatment cycles in which patients are free of severe toxicities, including neutropenia, thrombocytopenia, anemia, and febrile neutropenia. Researchers will also measure the proportion of treatment cycles patients complete without needing chemotherapy dose reductions, growth factors, or transfusions. They will also track grade 3/4 treatment-emergent adverse events, overall response, progression-free survival, and quality of life.
"This NSCLC trial represents important progress in our clinical development strategy, as it involves a p53-mutated cancer indication that affects one of the largest cancer patient populations, and it is our first randomized, double-blind, placebo-controlled trial," Aileron CEO Manuel Aivado said in statement.
The trial will also allow Aileron to pursue a tumor-agnostic indication for ALRN-6924 in any p53-mutated cancer, Aivado said. Aileron expects to report interim results from this trial in late 2021 and full results in mid-2022.
ALRN-6924 activates the normal p53 protein in patients' healthy cells, which temporarily pauses cell cycling. That pause helps protect normal cell cycling from being attacked by chemotherapy, which targets any cells that are cycling, including cancerous and healthy cells.
In October, Aileron presented data from a trial of ALRN-6924 in small cell lung cancer, which showed the drug reduced the occurrence of some severe side effects, like grade 3/4 anemia, thrombocytopenia, and neutropenia, in patients taking the chemotherapy drug topotecan.