A Phase I/II, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Gyn/Onc (OB/GYNONC), Thoracic (ONC)
Current Status: Open
Phase: I/II
Principal Investigator: Moore, Kathleen
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06799065?term=NCT06799065&viewType=Card&rank=1#participation-criteria
Summary
Primary:
- To determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) and to characterize the dose-limiting toxicities (DLTs) of ATX-295
- To evaluate safety and tolerability of ATX-295 at expected pharmacologically active dose(s) and/or schedule(s), including acute and chronic toxicities of ATX-295
Secondary:
- To describe the pharmacokinetics (PK) of ATX-295 in plasma
- To assess preliminary evidence of anti-tumor activity with ATX-295 treatment
- To evaluate pharmacodynamic (PD) effects of ATX-295 in tumor tissue in a subset of participants
Exploratory:
- To explore the potential relationship between ATX-295 PK parameters, tumor pharmacodynamics and pharmacogenetics
- To assess candidate biomarkers in tumor and/or blood to better understand the relationship between ATX-295 treatment, response, and resistance
- To evaluate the PD effects of ATX-295 in blood
- To evaluate the effect of ATX-295 on CYP3A4 metabolism
- To evaluate the preliminary effect of food on the PK of ATX-295
- To characterize potential metabolite(s) of ATX-295 in plasma
- To identify treatment emergent somatic mutation of resistance at relapse and assess utility of circulating tumor deoxyribonucleic acid (ctDNA) sequencing to determine minimal residual disease
- To characterize health-related quality of life (HRQoL) and participant-reported treatment-related safety of ATX-295