A Phase I/II Study of GB1275 Immunotherapy Alone, with Pembrolizumab Immunotherapy, or with Nab-paclitaxel and Gemcitabine in Patients with Advanced Digestive Cancers

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Full Title

A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination with an Anti-PD-1 Antibody in Patients with Specified Advanced Solid Tumors or in Combination with Standard of Care in Patients with Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 with Standard of Care or in Combination with an Anti-PD-1 Antibody in Patients with Specified Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug GB1275 that can be given safely alone or with other anticancer drugs in patients with metastatic digestive cancers, including pancreatic cancer, esophageal cancer, esophageal squamous cell cancer, gastric/gastroesophageal junction cancer, and “microsatellite-stable” colorectal cancer. Whether a patient receives GB1275 alone or as part of a combination treatment depends on the type of cancer and when they join the study.

GB1275 helps the immune system recognize and destroy cancer cells. Some study participants will receive GB1275 combined with the immunotherapy drug pembrolizumab, which also helps the immune system detect and kill cancer cells. Patients who have metastatic pancreatic cancer will receive GB1275 combined with nab-paclitaxel and gemcitabine, which are standard chemotherapy drugs used to treat pancreatic cancer.

GB1275 is taken orally (by mouth) and the other medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic cancer, esophageal cancer, esophageal squamous cell cancer, gastric/gastroesophageal junction cancer, or microsatellite-stable colorectal cancer that has come back or continued to grow despite prior treatment.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wungki Park at 646-888-4543.

Protocol

19-485

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators