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Exelixis Initiates Phase I Study of Anti-CDK7 Agent in Solid Tumors

NEW YORK – Alameda, California-based Exelixis on Monday announced that it has initiated a Phase I clinical trial evaluating its CDK7 inhibitor, XL102, as a treatment for patients with advanced solid tumors.

The trial will assess the safety, pharmacokinetics, and preliminary anti-tumor activity of XL102 as a monotherapy and with other anti-cancer agents. The first-in-human trial, which is expected to enroll nearly 300 patients, will be broken up into an initial dose-escalation portion followed by a dose-expansion stage that will stratify patients into cohorts based on cancer type. The cohorts will include patients with specific types of breast, ovarian, and prostate cancers.

In addition to evaluating the safety, preliminary activity, and maximum tolerated dose of XL102 in this Phase I trial, Exelixis will also consider the effect of XL102 on biomarkers.

According to Exelixis, which in-licensed XL102 from Aurigene in December 2020, the agent has demonstrated through preclinical studies its potential to inhibit tumor growth and induce cell death across different cancer types, including breast and gastric cancers.

"The initiation of our first-in-human Phase I trial of XL102 is an important step in our commitment to developing novel medicines that can help patients with cancer," Gisela Schwab, Exelixis' chief medical officer and president of product development and medical affairs, said in a statement. "The potential of this novel CDK7 inhibitor has been shown in preclinical studies demonstrating anti-proliferative activity and an ability to induce cell death in multiple cancer cell lines."