What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

What question did this study set out to answer?

This research assesses the safety and efficacy of onvansertib, a PLK1 inhibitor, in relapsed/refractory myeloproliferative chronic myelomonocytic leukemia (CMML).

December 8, 2025BloodOpen Access

MC210807: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML).

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Authors

SGSusan M. GeyerToyota Motor Corporation (Switzerland)KRKristen N. RiceHematology Oncology Associates RRRachel ReitherMayo Clinic

Discussion

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Implication

Phase 1 trial showed onvansertib's safety and preliminary efficacy in relapsed/refractory CMML, indicating potential for hematological response.

Key Points

This research assesses the safety and efficacy of onvansertib, a PLK1 inhibitor, in relapsed/refractory myeloproliferative chronic myelomonocytic leukemia (CMML).
Single center phase 1 study assessing safety and efficacy
Utilized a Bayesian Optimal Interval design to determine maximum tolerated dose (MTD)
Three dose cohorts (6, 9, and 12 mg/m2) administered orally for 28-day cycles
Evaluated response using MDS/MPN International Working Group Criteria
Conducted pharmacokinetic and translational correlative studies.
Nine patients enrolled with a median age of 68 years
No grade 3 or 4 toxicities attributed to onvansertib identified
Preliminary efficacy shown with 38% of patients meeting criteria for hematological response
Two patients noted evidence of optimal marrow response, supportive of treatment efficacy.

Cite This Study

Geyer et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e420 https://doi.org/10.1182/blood-2025-5634

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Implication

Phase 1 trial showed onvansertib's safety and preliminary efficacy in relapsed/refractory CMML, indicating potential for hematological response.

MC210807: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML).

Discussion

Member takes

Implication

Key Points

Cite This Study

MC210807: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML).

Discussion

Member takes

Implication

Key Points

Cite This Study

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