A Phase 1, Multi-Center, Safety, Dose Escalation, Pharmacokinetics of INV-1120 in Adult Patients Advanced Solid Tumors

Summary

Participation Requirements

Description

Phase 1, open-label dose-escalation study to determine the MTD and RP2D, and to assess the DLT of INV-1120 (also referred to as investigational product or IP). The safety, tolerability, and PK of INV-1120 will be assessed in adult patients with advanced solid tumors. Increasing doses of INV-1120 wil...

Phase 1, open-label dose-escalation study to determine the MTD and RP2D, and to assess the DLT of INV-1120 (also referred to as investigational product or IP). The safety, tolerability, and PK of INV-1120 will be assessed in adult patients with advanced solid tumors. Increasing doses of INV-1120 will be administered to cohorts of 3-6 participants, until the MTD or MAD is reached. The MTD will generally be considered as the RP2D. However, the RP2D may also be determined based on the data of pharmacokinetics, pharmacodynamic biomarkers in blood and the preliminary clinical activity of INV-1120, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1. The total number of patients enrolled in the study will depend upon the number of dose-escalation cohorts. It is estimated that approximately 36 evaluable patients will be enrolled in the dose-escalation part of this study. This multicenter study will be conducted in the United States.

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