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Phase 2 Study of ZN‑c3 in High-Grade Serous Ovarian Cancer
EU CTIS ID: 2022-502983-19-00
What this study is testing
Part 1b: To determine the safety and tolerability of azenosertib in subjects with PROC Part 2a: To investigate the antitumor activity of 2 dose levels of azenosertib in subjects with cyclin E1-positive PROC To investigate the safety and tolerability of 2 dose levels of azenosertib in subjects with cyclin E1-positive PROC Part 2b and 2 c: To investigate the antitumor activity of azenosertib in subjects with cyclin E1-positive PROC at the selected dose
- Therapeutic exploratory (Phase II)
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
- 1. Provision of signed ICF
- 2. Female Age ≥18 years (or age of majority in local region) at the time of informed consent.
- 3. Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
- 4. Subject must have platinum-resistant disease
- 5. Subjects must have received 1-3 prior lines of therapy (up to 4 if prior mirvetuximab) for Part 2 (up to 4 if prior mirvetuximab)
- 6. Prior mirvetuximab is required if approved and available for eligible subjects
You likely can't join if
- 1. Platinum refractory disease (in front line therapy)
- 2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
- 3. Any of the following treatment interventions within the specified time frame before C1D1: a. Hospitalization for any reason within 14 days c. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter); d. Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy. e. Autologous or allogeneic stem cell transplant within 3 months. f. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
- 4. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, CDK2 inhibitor, or PKMYT1 inhibitor.
- 5. Known hypersensitivity to any inactive ingredients present in azenosertib (refer to Investigator's Brochure).
- 6. A serious illness or medical conditions, listed in study protocol, including: h. Any evidence of small bowel obstruction as determined by air/fluid levels on CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
See the full eligibility criteria
- 1. Provision of signed ICF
- 2. Female Age ≥18 years (or age of majority in local region) at the time of informed consent.
- 3. Histologically or cytologically confirmed recurrent, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer
- 4. Subject must have platinum-resistant disease
- 5. Subjects must have received 1-3 prior lines of therapy (up to 4 if prior mirvetuximab) for Part 2 (up to 4 if prior mirvetuximab)
- 6. Prior mirvetuximab is required if approved and available for eligible subjects
- 7. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1
- 8. Performance Status: Eastern Cooperative Oncology Group (ECOG) score of ≤1.
- 9. Adequate hematologic and organ function during the Screening Period For the complete Inclusion Criteria, please refer to the study protocol
- 1. Platinum refractory disease (in front line therapy)
- 2. Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
- 3. Any of the following treatment interventions within the specified time frame before C1D1: a. Hospitalization for any reason within 14 days c. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter); d. Radiation therapy within 21 days; however, if the radiation portal covered ≤5% of the bone marrow, the subject is eligible irrespective of the end date of radiotherapy. e. Autologous or allogeneic stem cell transplant within 3 months. f. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
- 4. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, CDK2 inhibitor, or PKMYT1 inhibitor.
- 5. Known hypersensitivity to any inactive ingredients present in azenosertib (refer to Investigator's Brochure).
- 6. A serious illness or medical conditions, listed in study protocol, including: h. Any evidence of small bowel obstruction as determined by air/fluid levels on CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
- 7. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation). For the complete Exclusion Criteria, please refer to the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Korea, Republic of
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; Australia; Korea, Republic of. 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.