PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

Status Completed

Clinical Trial Summary

A Phase 1b, open-label, dose escalation study of PRS-343 in combination with atezolizumab in patients with HER2-positive advanced or metastatic solid tumors.

Clinical Trial Description

This is a multicenter, open-label Phase 1b study to determine the MTD and RP2D and to assess the safety and efficacy of PRS-343 administered in combination with atezolizumab, a PD-L1 antibody, in previously treated advanced or metastatic HER-2 positive solid tumors (e.g., bladder, breast and gastrointestinal). The study will include a dose escalation period followed by an expansion period. PRS-343 and atezolizumab will be given intravenously once every three weeks (Q3W). All available safety data, emerging PK, pharmacodynamic data, and dose limiting toxicities (DLTs) will be considered in guiding the Safety Committee's decisions regarding subsequent doses to be tested during the escalation phase of the study. Once the MTD and RP2D have been established, an expansion cohort will be enrolled. One treatment cycle is defined as 21 days (3 weeks). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03650348
Study type	Interventional
Source	Pieris Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	August 21, 2018
Completion date	August 11, 2022

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