CompletedPhase 1

A Study of Azenosertib (ZN-c3) in Participants With Solid Tumors

United States274 participantsStarted 2019-11-01

Plain-language summary

This is a Phase 1 open-label, multicenter study of ZN-c3 (also known as Azenosertib) monotherapy which consists of Dose Escalation, a Food Effect Cohort, and Dose Expansion.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Measurable or evaluable disease per RECIST version 1.1.
✓. 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.
✓. Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
✓. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
✓. Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.

Exclusion criteria

✕. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.
✕. Prior therapy with a WEE1 inhibitor.
✕. A serious illness or medical condition(s).
✕. 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.
✕. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
✕. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
✕. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).

What they're measuring

Dose Escalation

Timeframe: Through completion, average of 1 year

Food Effect Cohort

Timeframe: Through completion, approx 6 months

Food Effect Cohort

Timeframe: Through completion, approximately 6 months

Food Effect Cohort

Timeframe: Through completion approximately 6 month

Food Effect Cohort

Timeframe: Through completion, approximately 6 mth

Dose Expansion

Timeframe: Through completion, approximately 43 month

Trial details

NCT IDNCT04158336

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-06

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Measurable or evaluable disease per RECIST version 1.1.
✓. 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.
✓. Subjects must have no relevant dietary restrictions, and be willing to consume a high-calorie, high-fat breakfast and other standard meals provided during the study.
✓. Measurable disease, defined as at least one lesion that can be accurately measured per RECIST version 1.1 criteria.
✓. Recurrent or persistent USC or locally advanced or metastatic malignancy with one or more relevant biomarkers related to deoxyribonucleic acid (DNA) damage pathways.

Exclusion criteria

✕. Prior therapy with ZN-c3 or known hypersensitivity to any drugs similar to ZN-c3 in class or any inactive ingredients present in ZN-c3.
✕. Prior therapy with a WEE1 inhibitor.
✕. A serious illness or medical condition(s).
✕. 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.
✕. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
✕. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of \>480 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
✕. History or current evidence of congenital or family history of long QT syndrome or Torsade de Pointes (TdP).

What they're measuring

Dose Escalation

Timeframe: Through completion, average of 1 year

Food Effect Cohort

Timeframe: Through completion, approx 6 months

Food Effect Cohort

Timeframe: Through completion, approximately 6 months

Food Effect Cohort

Timeframe: Through completion approximately 6 month

Food Effect Cohort

Timeframe: Through completion, approximately 6 mth

Dose Expansion

Timeframe: Through completion, approximately 43 month