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Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

NCT05190445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-09-08

No results posted yet for this study

Summary

A Phase 2, multi-center, open-label study of cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel in patients with HER2-high and in combination with tucatanib in patients with HER2-low gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

  • HER2-positive Gastric Cancer

Interventions

DRUG

Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel

HER2/4-1BB

DRUG

Cinrebafusp alfa (PRS-343) in combination with tucatinib

HER2/4-1BB

Sponsors & Collaborators

  • Pieris Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gordon Otto, MD, PhD · Pieris Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-02-01
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190445 on ClinicalTrials.gov