ZN-c3 + Niraparib for Ovarian Cancer

Recruiting at 38 trial locations

Overseen By Project Director

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: K-Group Beta

Must not be taking: TdP risk medications

Disqualifiers: MDS, AML, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 30 months

117 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ZN-c3, alone and with niraparib, in patients with a type of ovarian cancer that doesn't respond to usual treatments. The drugs work by stopping cancer cell growth and preventing the cells from repairing themselves. Niraparib is an oral medication approved for use in ovarian cancer patients.

Eligibility Criteria

This trial is for women aged 18+ with high-grade ovarian, peritoneal, or fallopian tube cancer that's resistant to platinum therapy. They must have relapsed within 6 months of treatment and be willing to provide tissue samples. Participants need measurable disease and good organ function but can't join if they have certain heart conditions, uncontrolled blood pressure, gastrointestinal issues affecting absorption, a history of MDS/AML or are on drugs with TdP risk.

Inclusion Criteria

Have demonstrated relapse within 6 months of platinum therapy (platinum-free interval <6 months)

Willingness to release archival tissue for research purposes or to undergo a tumor tissue biopsy prior to dosing on Cycle 1 Day 1

Must have measurable disease according to RECIST V1.1 criterion: defined as at least one lesion that can be accurately measured

Exclusion Criteria

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)

A minimum of 10 days between termination of the prior PARPi and administration of ZN-c3 and niraparib treatment is required

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and ZN-c3 Monotherapy

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Niraparib
• ZN-c3

Trial Overview The study tests ZN-c3 alone and combined with niraparib in patients with platinum-resistant ovarian cancer. It aims to assess the safety and effectiveness of these treatments while also studying how the body processes them (pharmacokinetics) and their impact on the disease at a cellular level (pharmacodynamics).

Participant Groups

Group I: ZN-c3 and Niraparib Experimental Treatment 2 Interventions

ZN-c3 in combination with Niraparib

Group II: ZN-c3 Experimental Treatment 1 Intervention

ZN-c3 Monotherapy

Niraparib is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zejula for:

• Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
• Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

Approved in United States as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Who Is Running the Clinical Trial?

K-Group Beta

Lead Sponsor

Trials

6

Recruited

670+

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Lead Sponsor

Trials

8

Recruited

740+