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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel
- DRUG Cinrebafusp alfa (PRS-343) in combination with tucatinib
Study Locations (5)
California
- Sansum Clinic — Santa Barbara
Maryland
- Maryland Oncology-Hematology — Silver Spring
New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- University of Texas MD Anderson Cancer Center — Houston
Other
- Samsung Medical Center — Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05190445
The ClinicalTrials.gov registry entry for NCT05190445 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pieris Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HER2-positive Gastric Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05190445 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05190445 about?
NCT05190445 is a clinical study titled "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". 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.
What is the current status of trial NCT05190445?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2021-11-01. Estimated completion is 2023-02-01.
What conditions does trial NCT05190445 study?
This clinical trial studies the following conditions: HER2-positive Gastric Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05190445?
The interventions under investigation include: Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel (DRUG), Cinrebafusp alfa (PRS-343) in combination with tucatinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05190445?
This trial is sponsored by Pieris Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05190445 being conducted?
This trial has 5 study locations across California, Maryland, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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