A Study of ZN-c3 in Subjects With High-Grade | Clinical Research Studies Listing

Recruiting

18 years and older

All

Phase N/A

103 participants needed

1 Location

Brief description of study

The purpose of this study includes the following:

· To test the efficacy and safety of the Study Drug and to find out what effects, good and/or bad, it has on you and your cancer.

· To understand how the body absorbs and processes the Study Drug by measuring the amount of the Study Drug in the blood before, during and after receiving the Study Drug. (This is called pharmacokinetics (PK) testing).

Detailed description of study

Tests and Procedures

If you choose to participate and sign and date the consent forms, you will need to have tests or procedures done to confirm if you can be in the study. This is called the Screening Period. If the results of the tests show that you can be in the study, you will enter the study treatment period, and begin to receive Study Drug.

How the Study Drug Will Be Given

You will be asked to take a specific amount of the Study Drug by mouth at approximately the same time each day. The Study Drug will be given to you in a plastic medication bottle.

You will also be given a subject diary to record (1) each dose that you take and the time you take it and (2) each dose you missed, if any, or if the dose was taken 8 hours or more later than the scheduled time. You will need to bring the diary and the bottle containing the Study Drug (even if it is empty) with you to each clinical visit.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Cancer; locally advanced or metastatic solid tumor malignancies
Age: 18 Years
Gender: All

Inclusion Criteria:

Age ≥18 years
High-grade serous ovarian cancer
Prior therapy:
1. Subjects must have platinum-resistant disease
2. One to 4 prior lines or regimens are allowed (1 to 5 prior lines are permitted in part 1b)
3. Prior bevacizumab treatment is required
Measurable disease per RECIST Version 1.1.
Adequate hematologic and organ function

Exclusion Criteria:

Any of the following treatment interventions within the specified time frame prior to C1D1:
1. Major surgery within 28 days
2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter);
3. Radiation therapy within 21 days;
4. Autologous or allogeneic stem cell transplant within 3 months.
5. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor.
A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1 D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1 D1.

Updated on 01 Aug 2024. Study ID: 851536

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