Advancing Treatment Possibilities Through Evidence.
Turning insight into impact through clinical research
Zentalis is dedicated to providing a new treatment option by unlocking the potential of WEE1 inhibition. Our team understands the unmet needs in patient care today and is focused on delivering an oral, biomarker-driven, chemotherapy-free regimen that makes ovarian cancer treatment more convenient and patient-centered.
our comprehensive clinical program is evaluating azenosertib as both monotherapy and as a combination therapy.
our comprehensive clinical program is evaluating azenosertib as both monotherapy and as a combination therapy.
Important: azenosertib is an investigational therapy and has not yet been approved by any regulatory agency. Only your doctor can determine if a clinical trial may be right for you.
ASPENOVA phase 3 clinical trial.
ASPENOVA is a Phase 3 randomized, controlled clinical trial to evaluate azenosertib (ZN-c3) versus standard-of-care chemotherapy in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). NCT07546500
DENALI phase 2 clinical trial.
DENALI is a multi-part Phase 2 clinical trial to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with platinum-resistant ovarian cancer. Part 1b demonstrated promising objective response rates and durable responses in Cyclin E1-positive population. Part 2, designed as a registration-intent trial, is ongoing.
MUIR phase 1 clinical trial.
MUIR is a Phase 1 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in combination with multiple chemotherapy backbones and bevacizumab in ovarian cancer. Enrollment is ongoing studying azenosertib in combination with bevacizumab in earlier lines of ovarian cancer. NCT04516447
investigator-sponsored trial.
Phase 1 Combination Clinical Trial in HER2-expressing Solid Tumors
This clinical trial is evaluating the safety and efficacy of combining azenosertib with trastuzumab deruxtecan in stomach or other solid tumors. NCT06364410
expanded access policy
Zentalis is dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Currently, Zentalis’ clinical product candidates are in clinical development, not yet approved by health authorities, such as the U.S. FDA, and therefore are “investigational drugs.” This phase of development means that more clinical studies are required and that health authorities have not yet found these products to be safe and effective for their specific use. Zentalis’ position is that clinical trial programs are the primary way to access our investigational drugs prior to regulatory approval and we encourage patients to speak with their doctors to determine potential benefits, risks and eligibility to participate in such a clinical trial.
Generally, Zentalis does not provide investigational drugs to patients until there is sufficient data on the safety and efficacy of our products to allow patients and physicians to assess the risks and benefits of using these investigational drugs outside of a clinical trial context. Therefore, at this time, Zentalis is not currently offering access to its investigational drugs outside of clinical trials.
In the future, Zentalis may assess whether to provide expanded access for its investigational drugs as they advance further in clinical trials and more data to support safety and effectiveness become available.
Posting this policy by Zentalis does not guarantee access to any specific investigational drug for any individual patient.
You can find additional information about Zentalis’ ongoing clinical trials on our website and by accessing https://clinicaltrials.gov.
If you have additional questions, please speak with your treating physician or contact Zentalis at [email protected].