NEW YORK – ABM Therapeutics on Thursday said it began a Phase I trial of its MEK inhibitor ABM-168 in solid tumors with RAS, RAF, or NF-1 alterations.
Investigators will evaluate ABM-168 in 112 patients in a two-part trial. In the part A dose-escalation study, patients with advanced or metastatic solid tumors who have no remaining standard therapy options will receive ABM-168 once a day until disease progression, intolerable toxicity, or other criteria for withdrawal are met. In the part B dose-expansion study, patients with solid tumors bearing RAS, RAF, or NF-1 mutations with certain cancers, including melanoma, and colon, lung, pancreatic, or primary central nervous system cancers, will receive ABM-168 once daily on a continuous schedule. Outcome measures of the trial will include maximum tolerated dose, recommended Phase II dose, safety, and tolerability.
In preclinical studies, ABM-168 has shown high cell permeability and brain penetration, as well as anti-cancer activity in animal models.
The San Diego- and Shanghai-based company is particularly interested in developing ABM-168 as a combination therapy. "A MEK inhibitor in combination with a BRAF inhibitor has been demonstrated to be more effective and less toxic than a single BRAF inhibitor, which has become the standard of care for patients with BRAF-mutated melanoma," ABM Founder and CEO Chen Chen said in a statement. "The combination of a MEK inhibitor with other anti-cancer drugs such as KRAS inhibitors and PD-1/PD-L1 antibodies is also [being] explored. We look forward to early clinical data which will help us figure out the most effective combination for treating cancers, particularly those with high brain metastasis rates."
ABM is also advancing a BRAF inhibitor, ABM-1310, as a treatment for patients with BRAF V600E mutated cancers in a Phase I clinical trial.