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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04095390` - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer	Phase 2
Recruiting	`NCT04578106` - Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy	Phase 2
Terminated	`NCT01912963` - Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer	Phase 2
Completed	`NCT01855828` - Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer	Phase 2
Terminated	`NCT01705340` - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery	Phase 1
Recruiting	`NCT04094896` - TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer	Phase 2
Recruiting	`NCT06087120` - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting	`NCT05346861` - Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab	Phase 3
Recruiting	`NCT04899908` - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases	Phase 2
Completed	`NCT03330561` - PRS-343 in HER2-Positive Solid Tumors	Phase 1
Recruiting	`NCT04997798` - Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer	Phase 2
Not yet recruiting	`NCT04034823` - KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer	Phase 2
Completed	`NCT04756921` - 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Completed	`NCT03140553` - TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer	Phase 2
Completed	`NCT03094052` - Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib	Phase 2
Recruiting	`NCT05511844` - Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors	Phase 1
Recruiting	`NCT05325632` - Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab	Phase 2
Recruiting	`NCT06161922` - Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Recruiting	`NCT05710666` - Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)	Phase 2
Not yet recruiting	`NCT05063643` - Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude