Spots Global Cancer Trial Database for PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

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Trial Identification

Brief Title: PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

Official Title: 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

Study ID: NCT03650348

Conditions

HER2-positive Breast Cancer

HER2-positive Gastric Cancer

HER2-positive Bladder Cancer

HER2-positive Solid Tumor

Interventions

PRS-343 in Combination with Atezolizumab

Study Description

Brief 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).