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Phase 1/2 Study of ZN-c3 and Niraparib and ZN-c3 Monotherapy in Platinum-Resistant Ovarian Cancer
EU CTIS ID: 2024-515196-35-00
What this study is testing
ZN-c3 in combination with niraparib: Phase 1b: To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D Phase 2: To investigate the antitumor activity of ZN-c3 in combination with niraparib ZN-c3 monotherapy: To determine the safety and tolerability of ZN-c3 monotherapy To investigate the antitumor activity of ZN-c3 monotherapy
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
- Subjects must have platinum-resistant disease.
- Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
- Adequate hematologic and organ function.
- Ability and willingness to take oral medication.
- Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.
You likely can't join if
- Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration).
- Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter)
- A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
- Any investigational drug therapy <28 days.
- Prior treatment with a WEE1 inhibitor.
- Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
See the full eligibility criteria
- Histologically or cytologically confirmed recurrent high grade epithelial ovarian, primary peritoneal, or fallopian tube cancer with histologic subtypes of serous, clear cell or endometroid for which there is no known or established treatment available with curative intent.
- Subjects must have platinum-resistant disease.
- Must have evaluable or measurable disease according to RECIST v1.1 criterion: defined as at least one lesion that can be accurately measured.
- Adequate hematologic and organ function.
- Ability and willingness to take oral medication.
- Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer.
- Major surgery within 28 days (any surgical incision should be fully healed prior to study drug administration).
- Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter)
- A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required.
- Any investigational drug therapy <28 days.
- Prior treatment with a WEE1 inhibitor.
- Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or its excipients.
- Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg).
- Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV). Significant gastrointestinal abnormalities, requirement for IV alimentation, active peptic ulcer, chronic diarrhea, or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.