NCT03650348

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Pieris Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• HER2-positive Breast Cancer
• HER2-positive Gastric Cancer
• HER2-positive Bladder Cancer
• HER2-positive Solid Tumor

Interventions

Type	Name	Description
DRUG	PRS-343 in Combination with Atezolizumab	HER2/4-1BB Bispecific

Timeline

• Start date: 2018-08-21
• Primary completion: 2022-08-11
• Completion: 2022-08-11
• First posted: 2018-08-28
• Last updated: 2024-04-22

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study