Asana BioSciences is enrolling participants for a Phase 1 clinical trial assessing the safety, tolerability, and effectiveness of AS003 in patients with advanced solid tumors with the BRAF V600 mutation or with alterations in the PI3K pathway.
“We are delighted to initiate the clinical development of ASN003, which is a first-in-class highly selective BRAF/PI3K inhibitor designed to delay or treat acquired resistance observed in patients treated with current therapies targeting these individual pathways. The dosing of the first cohort in the trial has been completed, and the drug was well tolerated,” Sandeep Gupta, PhD, president and CEO at Asana BioSciences, said in a news release.
“ASN003 is our third clinical stage program in less than two years, affirming Asana’s efficiency and dedication to provide new and better treatment options to cancer patients,” Gupta said.
Activation of the BRAF or PI3K pathways has been widely implicated in abnormal cell growth in several cancer types, including colorectal, melanoma, breast, and lung cancers.
ASN003 has shown higher anti-tumor activity in preclinical studies than drugs that exclusively inhibit the BRAF pathway, like Zelboraf (vemurafenib) or Tafinlar (dabrafenib), according to Asana. ASN003 has also shown promising anti-proliferative activity in cell lines that are resistant to BRAF and MEK inhibitors.
The Phase 1, open-label, multicenter, dose-finding study (NCT02961283) was designed to assess the safety, tolerability, drug properties, and anti-tumor activity of ASN003 in patients with metastatic colorectal cancer, advanced non-small cell lung cancer, and other advanced solid tumors.
The study is divided into two parts. The first part will test various doses of ASN003 to find the highest safe dose to test in three specific groups. In the second part, researchers will test the effectiveness of the selected dose. Patients will be enrolled into one of three groups: those with metastatic or recurrent melanoma with the BRAF V600 mutation; patients with metastatic colorectal cancer or advanced non-small cell lung cancer with the BRAF V600 mutation; and patients with advanced solid tumors with alterations in the PI3K pathway.
The study is currently enrolling participants and is expected to include up to 100 patients. The completion date is estimated to be December 2019. For information about enrolling, visit NCT02961283.