The phase 1b/2 trial is a multi-center, open-label trial to evaluate PCM-075 in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory.
In the phase 1b dose-escalation segment of the trial, the primary objective is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), using a traditional 3+3 design.
In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of PCM-075 in combination with standard-of-care chemotherapy.
PCM-075 is an oral highly-selective adenosine triphosphate competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid tumor cancers.
The drug has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents.
Trovagene is developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring technology in tumor genomics.
The company has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.
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