Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa (PRS-343) in Combination With Ramucirumab and Paclitaxel in Patients With HER2-Positive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With Tucatinib in Patients With HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study ID: NCT05190445
Conditions
Study Description
Brief 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.
Detailed Description: This is a multi-center, open-label study of cinrebafusp alfa in combination with clinically established doses of ramucirumab and paclitaxel in patients with HER2-positive (IHC 3+ or IHC 2+ with HER2/neu gene amplification) gastric or GEJ adenocarcinoma (Arm 1) and in combination with tucatinib in patients with low levels of HER2 (IHC 1+ or IHC 2+ without HER2/neu amplification) (Arm 2).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sansum Clinic, Santa Barbara, California, United States
Maryland Oncology-Hematology, Silver Spring, Maryland, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Samsung Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Gordon Otto, MD, PhD
Affiliation: Pieris Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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