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Monoclonal Antibodies
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
Phase 2
Waitlist Available
Research Sponsored by Pieris Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment called cinrebafusp alfa combined with other cancer drugs in patients with stomach or GEJ cancer. It targets a protein called HER2 to help the immune system destroy cancer cells.
Eligible Conditions
- HER2 Positive Gastric Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cinrebafusp alfa (PRS-343) in combination with tucatinibExperimental Treatment1 Intervention
Patients aged 18 years or older with HER2 low (IHC 1+ or IHC 2+ without HER2/neu amplification) gastric or GEJ adenocarcinoma who have received at least one prior treatment regimen
Group II: Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxelExperimental Treatment1 Intervention
Patients aged 18 years or older with HER2-positive gastric or GEJ adenocarcinoma who have progressed on prior treatment with a regimen containing a platinum and fluoropyrimidine and a HER2-directed therapy such as trastuzumab and now are candidates for treatment with ramucirumab and paclitaxel
Find a Location
Who is running the clinical trial?
Pieris Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
171 Total Patients Enrolled
Tim Demuth, MD, PhDStudy DirectorPieris Pharmaceuticals, Inc.
1 Previous Clinical Trials
45 Total Patients Enrolled
Gordon Otto, MD, PhDStudy DirectorPieris Pharmaceuticals, Inc.