A Phase II Study of Cinrebafusp Alfa with Ramucirumab and Paclitaxel in People with Gastric or Gastroesophageal Junction Cancer

Share

Full Title

A Phase 2, Multi-Center, Open-Label Study of Cinrebafusp Alfa (PRS-343) in Combination with Ramucirumab and Paclitaxel in Patients with HER2-Postive Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination with Tucatinib in Patients with HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Purpose

Ramucirumab and paclitaxel are standard chemotherapy drugs used to treat cancer of the stomach (gastric cancer) or gastroesophageal junction (GEJ, the union of the esophagus and stomach), regardless of whether these cancers produces the HER2 protein. In this study, researchers are determining the safety and effectiveness of giving the investigational drug cinrebafusp alfa (also called PRS-343) with ramucirumab and paclitaxel in people with HER2-positive gastric or GEJ cancer that has continued to grow despite treatment.

Cinrebafusp alfa targets the HER2 protein on cancer cells and another protein (called CD137) on immune cells and stimulates the immune system to attack HER2-positive cancer cells. All of the medications used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HER2-positive gastric or GEJ cancer that came back or continued to grow despite one or two prior regimens of treatment. These treatments must have included the drug trastuzumab, which blocks HER2.
  • Patients must recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Geoffrey Ku at 646-888-4588.

Protocol

21-461

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators