Trial to Assess Dose Escalation of Experimental Drug Plus Immunotherapy in Solid Tumors Begins

A phase 1b trial of XL092, a novel tyrosine kinase inhibitor (TKI), has begun recruiting patients with advanced solid tumors. Researchers plan to use the drug in combination with Opdivo (nivolumab) and Yervoy (ipilimumab), as well as with Opdivo and another experimental anti-cancer drug bempegaldesleukin.

The aim of the STELLAR-002 trial is to determine the safety, tolerability and efficacy of XL092. Exelixis, Inc. announced that the dose escalation stage of the trial has started.

XL092 is an oral TKI that targets kinases that causes cancer growth and spread. It is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers (those that affect the urinary tract, prostate, testicles or penis), as both a monotherapy and in combination with immune checkpoint inhibitors.

“The initiation of the dose-escalation stage of STELLAR-002, our second phase 1b trial of XL092, is an important step toward evaluating the potential of this next-generation tyrosine kinase inhibitor in combination with three additional immuno-oncology therapies for patients with advanced genitourinary tumors,” said Michael M. Morrissey, president and chief executive officer of Exelixis, in a statement.

The dose escalation stage of XL092 will be used to figure out what the best recommended dose is for patients with advanced solid tumors, depending on the combination therapy regimen. After the proper dose is determined, the researchers hope to begin enrolling tumor-specific expansion groups of patients with advanced renal cell carcinoma, urothelial carcinoma and metastatic castration-resistant prostate cancer.

The trial plans to use objective response rates — which shows the percentage of patients whose tumors respond to the treatment — for the primary efficacy endpoint of the expansion stage. For the group of patients with metastatic castration-resistant prostate cancer, researchers plan to use duration of radiographic progression-free survival (time from study enrollment to disease progression via radiographic imaging) as the primary endpoint.

Researchers intend to examine 826 patients — non-randomized — in the trial, which has an estimated completion date of May 2026. Patients are currently being recruited at an Exelixis site in Tucson, Arizona.

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