NCT06015659

ZN-c3 + Gemcitabine in Pancreatic Cancer

Phase 2 Single Arm Trial Testing the ZN-c3 WEE1 Inhibitor in Combination With Gemcitabine in Second-Line Advanced Pancreatic Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Brandon Huffman, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to test the safety and effectiveness of combining ZN-c3 and Gemcitabine in participants with pancreatic cancer. The names of the study drugs involved in this study are: * ZN-c3 (a small molecule inhibitor of the WEE1 tyrosine kinase) * Gemcitabine (a nucleoside metabolic inhibitor)

Detailed description

This is an open label, single arm phase 2 trial evaluating ZN-c3 combined with gemcitabine in second-line advanced pancreatic cancer. There are lab experiments that show that pancreatic cancer cells can respond to a combination of ZN-c3, an experimental drug, with gemcitabine. The U.S. Food and Drug Administration (FDA) has not approved ZN-c3 as a treatment for any disease. The FDA has approved gemcitabine as a treatment option for advanced pancreatic cancer. The research study procedures include screening for eligibility, study treatment including evaluations and follow up visits, radiological scans (Computerized Tomography, Magnetic Resonance Imaging, or Positron Emission Tomography), blood tests, electrocardiogram, and tumor biopsy. It is expected that about 34 people will take part in this research study. The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are supporting this research study by providing funding to conduct the study. Zentalis is supplying the study drug, ZN-c3.

Conditions

• Advanced Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Zentalis	Small molecule inhibitor of the WEE1 tyrosine kinase, tablet taken orally per protocol.
DRUG	Gemzar	Nucleoside metabolic inhibitor, per standard care via intravenous infusion.

Timeline

• Start date: 2023-11-16
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-08-29
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study