Investigational drug GB1275 in combo with standard therapy for Advanced or Metastatic Cancers - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drug, GB1275, is safe and effective for shrinking your cancer.

What is the Condition Being Studied?

Advanced or Metastatic Cancer

Who Can Participate in the Study?

Adults with one of the following types of cancer:
-Esophageal cancer (cancer of the esophagus)
-Gastric adenocarcinoma (a type of stomach cancer)
-Gastroesophageal junction adenocarcinoma (a type of cancer that occurs where the esophagus meets the stomach)
-Pancreatic adenocarcinoma (a type of cancer of the pancreas)
-Triple-negative breast cancer (breast cancer that is missing certain receptors)
-Castrate-resistant prostate cancer (prostate cancer that doesn’t respond to homone-blocking therapies)
-Lung cancer
-Head and neck squamous cell carcinoma
-Urothelial carcinoma (a type of cancer found in the bladder or kidneys)
-Renal cell carcinoma (a type of kidney cancer)
-Hepatocellular carcinoma (a type of liver cancer)

Age Group

What is Involved?

If you choose to join this study, you will:
-Take the study drug, GB1275, by mouth 2 to 3 times a day
-Give blood and urine samples
-Have regular CT or MRI scans

Some people will also:
-Get pembrolizumab into the vein (IV) once every 21 days; or
-Get nab-paclitaxel and gemcitabine into the vein (IV) on days 1, 8, and 15 of 28-day cycles

Study Details

Full Title
[GB1275-1101] 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
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00105034
NCT: NCT04060342
Phase I/II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center