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news.Ignyta announced that Cancer Research UK has initiated a new, investigator-sponsored Phase 1/1b clinical trial of a combination of paclitaxel with taladegib - the company's novel, orally available, hedgehog/smoothened inhibitor - in patients with platinum-resistant, recurrent ovarian cancer or recurrent, advanced solid tumors.
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This clinical trial is an open label dose-escalation and expansion study designed to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), tolerability, pharmacokinetics and preliminary clinical activity of the combination of taladegib and weekly paclitaxel in this patient population.
The lead investigator will be Dr. Rosalind Glasspool of the Beatson West of Scotland Cancer Centre, Glasgow, Scotland.
Ignyta chairman and CEO Jonathan Lim said: "We are excited that Cancer Research UK has expanded the clinical investigation of taladegib through the initiation of this combination study.
"We look forward to supporting Cancer Research UK in this trial, and to evaluating the data, including potentially identifying the impact of this therapeutic intervention on the hedgehog pathway at both the mRNA and protein levels and correlating these changes with the patients’ disease and potential clinical response."
About Taladegib
Taladegib, which Ignyta exclusively licensed from Eli Lilly and Company in November 2015, is a potent, orally bioavailable small molecule hedgehog/smoothened antagonist that has achieved clinical proof-of-concept and a recommended Phase 2 dose based on results from prior clinical studies. Ignyta believes taladegib represents a potential first-in-class hedgehog/smoothened inhibitor for second-line treatment of locally advanced or metastatic basal cell carcinoma, as well as a potential best-in-class hedgehog/smoothened inhibitor for first-line treatment of these patients.
In addition, Ignyta believes taladegib alone or in combination has the potential to treat selected patients with solid tumors outside of basal cell carcinoma that are driven by hedgehog pathway alterations. Ignyta also granted back to Lilly exclusive rights for Lilly to develop and commercialize taladegib-containing products in combination with certain Lilly compounds.