RBN-2397, an Oral PARP7 Inhibitor, in Patients With Solid Tumors , FIH, MAD Study

Summary

Participation Requirements

Description

This is a first-in-human, Phase 1, multi-center, open-label, dose-escalation study to: Evaluate the safety profile and MTD of RBN-2397 administered orally and establish the RBN-2397 dose(s) and schedule(s) recommended for further investigation in Phase 2 Characterize the PK profile of RBN-2397 Ident...

This is a first-in-human, Phase 1, multi-center, open-label, dose-escalation study to: Evaluate the safety profile and MTD of RBN-2397 administered orally and establish the RBN-2397 dose(s) and schedule(s) recommended for further investigation in Phase 2 Characterize the PK profile of RBN-2397 Identify preliminary antitumor activity. Biomarkers and their correlation with response to RBN-2397 and other outcomes will be examined. Cohorts will follow a traditional 3 + 3 design. After enrollment of the first participant within a cohort, there must be a wait period of at least 1 week before enrollment of additional participants in that cohort. After the MTD is determined, Expansion Cohort(s) of approximately 20 participants each will be enrolled to further examine the safety, PK, pharmacodynamics, and antitumor activity of RBN-2397 at the MTD or other dose recommended for further investigation. Based on nonclinical data as well as clinical data obtained from the dose-escalation portion of this study, enrollment in the Expansion Cohort(s) may be limited to specific tumor type(s), as warranted by the data.

Tracking Information