A Study of ZN-c3 in Participants With Solid Tumors

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ZN-c3 on its own. It focuses on patients with specific advanced cancers that have DNA damage. The drug aims to stop cancer cell growth by targeting these damaged cells.

Eligibility Criteria

Inclusion Criteria

Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.

Age ≥ 18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.

Subjects must have a solid tumor with advanced or metastatic disease, refractory to standard therapy or for whom no standard therapy is available, or the subject is ineligible for standard therapy(ies).

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Exclusion Criteria

Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia or skin pigmentation).

Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to C1D1.

You have previously been treated with ZN-c3 or have had an allergic reaction to drugs similar to ZN-c3 or any inactive ingredients in ZN-c3.

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Treatment Details

Interventions

ZN-c3 (Other)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Single Agent Food Effect CohortExperimental Treatment1 Intervention

Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available. This cohort will give subjects the option to continue treatment after PK assessments are completed.

Group II: Single Agent Dose ExpansionExperimental Treatment1 Intervention

Subjects with histologically confirmed recurrent or persistent USC who have had treatment with at least 1 prior platinum-based chemotherapy regimen for management of advanced or metastatic USC and subjects with locally advanced or metastatic malignancy with one or more relevant biomarkers related to DNA damage pathways.

Group III: Single Agent Dose EscalationExperimental Treatment1 Intervention

Subjects with solid tumors with advanced or metastatic disease who are refractory or ineligible to standard therapy(ies) or for whom no standard therapy is available.