ZN-c3 for Serous Carcinoma

Phase 2

Waitlist Available

Research Sponsored by K-Group Beta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have platinum-resistant disease

Age ≥18 years

Must not have

Radiation therapy within 21 days prior to C1D1

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug, ZN-c3, on people with cancer that has spread to other parts of the body. The drug will be given to see if it is effective and safe.

Who is the study for?

This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who've had up to three prior treatments including bevacizumab. They must have a measurable lesion and an ECOG performance status of ≤1. Participants need to agree to contraception use during and after the trial for specified periods.

What is being tested?

The study tests ZN-c3's effectiveness, safety, how it moves through the body (pharmacokinetics), and its impact on certain biomarkers in patients with specific types of advanced gynecological cancers that have worsened within six months despite treatment.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions related to drug ingredients or those common in cancer therapies such as fatigue, nausea, blood count changes. Specific side effects will depend on ZN-c3's action mechanism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition did not improve with platinum-based chemotherapy.

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I am 18 years old or older.

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I have high-grade serous ovarian cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had radiation therapy in the last 3 weeks.

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I don't have serious illnesses like recent bowel blockages or need for frequent fluid removal.

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I haven't had chemotherapy or targeted therapy in the last 14 days or 5 half-lives, whichever is shorter.

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I have not had major surgery in the last 4 weeks.

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I have not taken ZN-c3 or similar drugs targeting cancer cell growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months for reporting.