A Phase I, First-in-Human Study of MEN2501, a KIF18A Inhibitor, as Monotherapy in Participants with Platinum-Resistant Ovarian Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: I
Principal Investigator: Moore, Kathleen
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07226427?term=NCT07226427&viewType=Card&rank=1#participation-criteria
Summary
Primary:
- Part A: To identify the maximum tolerated dose (MTD)/ maximum administrated dose (MAD) and recommended expansion doses for MEN2501 in platinum-resistant ovarian cancer
- Part B: Establish the recommended phase 2 dose (RP2D) of MEN2501
Secondary:
- Evaluate the safety and tolerability of MEN2501- To evaluate preliminary antitumor activity of MEN2501- Characterize the PK profile of MEN2501 in plasma and urine and evaluate the effect of food
Exploratory:
- Evaluate the PD effect of MEN2501 in modulating the mutational profile
- Evaluate the PD effect of MEN2501 in modulating the CA125 Biomarker
- Evaluate the aneuploidy status and the tumor fraction- Evaluate TP53 and HRD status and / or other available biomarkers
- Evaluate exposure-response for efficacy and safety for MEN2501- Evaluate the relationship between drug circulating levels and QTc for MEN2501
- Part B: Characterize the metabolite profile of MEN2501 in plasma and urine
- Exploratory assessment of MEN2501 drug-drug interaction risk as potential CYP3A4 inducer and OATP1B inhibitor