Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-19 @ 12:08 PM
Study NCT ID:
NCT06015659
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2023-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZN-c3 + Gemcitabine in Pancreatic Cancer
Sponsor:
Brandon Huffman, MD
Organization:
Study Overview
Official Title:
Phase 2 Single Arm Trial Testing the ZN-c3 WEE1 Inhibitor in Combination with Gemcitabine in Second-Line Advanced Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: