Trovagene announced completion of the first dose cohort of PCM-075, a highly-selective Polo-like Kinase 1 (PLK1) Inhibitor, in combination with decitabine, in its Phase 1b/2 clinical trial in patients with Acute Myeloid Leukemia (AML).
Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine. The combination of PCM-075 and decitabine was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at 18 mg/m2 of PCM-075 (approximately a 50% increase) in combination with decitabine.
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This is the second dose cohort to be completed in the Phase 1b/2 open-label AML study of PCM-075 in combination with standard-of-care chemotherapy. In May 2018, Trovagene announced the successful completion of the first dose cohort of three patients treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with low-dose cytarabine (LDAC). Achieving this milestone enabled the initiation of recruitment and enrollment of the next three-patient cohort for dosing of PCM-075 at 18mg/m2, administered once daily, on days 1-5 of the treatment cycle, in combination with LDAC.
The PCM-075 dose level may be increased by 50% increments on either LDAC or decitabine in successive cohorts of three patients until a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) is achieved. The MTD or RP2D will be used in the Phase 2 segment of the trial to evaluate antitumor activity and to continue to assess the safety and tolerability of PCM-075 in combination with standard-of-care chemotherapy.
"We are pleased that the combination of PCM-075 and decitabine was well tolerated and that the SRC recommended we advance to our second dose cohort," said Bill Welch, Chief Executive Officer of Trovagene. "We are excited to be moving forward with the next dose level of PCM-075 (18 mg/m2) in combination with standard-of-care chemotherapy – cytarabine or decitabine – in our Phase 1b dose escalation trial, with each cohort enrolling three patients, respectively."