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Monoclonal Antibodies

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

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
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Signed written informed consent obtained prior to performing any study procedure, including screening procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial is testing a new drug, cinrebafusp alfa, to see if it can help treat stomach or gastroesophageal junction cancer.

Eligible Conditions
  • HER2 Positive Gastric Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Secondary outcome measures
Disease control rate (DCR, CR+PR+SD)
Duration of response (DOR)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
+3 more
Other outcome measures
AUC0-tlast of cinrebafusp alfa in Cycles 1 and 2
Cmax f cinrebafusp alfa in Cycles 1 and 2
Compare levels of HER2 and HER2 gene amplification in an archival tissue specimen and in a tumor biopsy specimen collected after completion of prior HER2-directed therapy
+5 more

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
260 Total Patients Enrolled
Tim Demuth, MD, PhDStudy DirectorPieris Pharmaceuticals, Inc.
1 Previous Clinical Trials
130 Total Patients Enrolled
Gordon Otto, MD, PhDStudy DirectorPieris Pharmaceuticals, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction Cinrebafusp alfa (PRS-343) in conjunction with ramucirumab and paclitaxel?

"With no proven efficacy yet, but with data indicating safety, our experts at Power have rated the combination of Cinrebafusp alfa (PRS-343), ramucirumab and paclitaxel a 2."

Answered by AI

How widely accessible is this research endeavor?

"As of now, the study is being conducted in four locations; these cities consist of Santa Barbara, Houston and New york among a few others. To reduce transit burden for participants, it is beneficial to select the site most proximal to your place of residence if you decide to join."

Answered by AI

What is the aggregate amount of participants enrolled in this trial?

"Presently, this research is not open for enrolling new participants. The trial was first listed on November 1st 2021 and underwent its most recent update September 7th 2022. If you are hunting for other studies that may suit your needs, there are 1173 trials recruiting persons with stomach cancer and 875 trials looking to recruit patients who will receive PRS-343 in conjunction with ramucirumab as well as paclitaxel."

Answered by AI

What situations warrant the combination of Cinrebafusp alfa (PRS-343), ramucirumab, and paclitaxel?

"Cinrebafusp alfa (PRS-343) can be utilized in conjunction with ramucirumab and paclitaxel to treat various conditions including locally advanced non-small cell lung cancer, metastatic bladder cancer, and acquired immunodeficiency syndrome."

Answered by AI

Are there any ongoing opportunities for individuals to participate in this research?

"This research programme is no longer accepting recruits. It was initially released on November 1st 2021 and then last amended on September 7th 2022. However, there are 1173 clinical trials for stomach cancer that are open to new participants and 875 studies recruiting patients interested in the combination of Cinrebafusp alfa (PRS-343), ramucirumab, and paclitaxel."

Answered by AI

Could you please detail the previous research that has been conducted using PRS-343 alongside ramucirumab and paclitaxel?

"At present, 875 clinical trials are being conducted to investigate the efficacy of Cinrebafusp alfa (PRS-343), ramucirumab and paclitaxel. Of these studies, 234 have entered Phase 3 with Woolloongabba in Queensland acting as a major research hub. Furthermore, 49079 sites across the globe are evaluating this potential therapy."

Answered by AI
~24 spots leftby Mar 2025