Onconova Therapeutics has dosed the first patient in its Phase I/IIa clinical trial of narazaciclib combined with letrozole to treat endometrial cancer.
The multicentre, open-label study will evaluate narazaciclib in combination with letrozole as a second or third-line treatment for patients with recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC).
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The company intends to conduct the trial at the study’s principal investigator site, sites affiliated with MD Anderson Cancer Center, US Oncology Research sites, and NYU Langone Health.
The Phase I dose escalation portion of the trial will be initiated first followed by a Phase II expansion cohort.
Determining a recommended Phase II dose (RP2D) by evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of the combination is the primary objective of the Phase I portion.
Phase II expansion cohort will enrol over 30 patients and its primary objective is to evaluate the efficacy of the combination at the RP2D, as measured by 24-week progression-free survival.
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By GlobalDataIn addition, exploratory objective of the study is to record the estrogen/progesterone receptor status of participants.
Onconova president and CEO Steven Fruchtman said: “Our recurrent LGEEC programme provides an opportunity to establish narazaciclib as a best-in-class therapy in an indication where clinical proof-of-concept for its mechanism of action has been demonstrated.
“We, therefore, view the programme as a key avenue for value creation and look forward to our Phase I/IIa trial’s preliminary data readout expected later this year.”
A multi-kinase inhibitor, narazaciclib targets CDK 4, CDK 6, and other kinases which are important for cell proliferation and motility.
