ZN-c3 for Bladder Cancer

Site 0167, Newport Beach, CA
Bladder Cancer+9 More ConditionsZN-c3 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new drug, ZN-c3, to see if it is safe and effective when used alone or with other drugs.

Eligible Conditions
  • Bladder Cancer
  • Metastatic Breast Cancer
  • Solid Tumors
  • Breast Cancer
  • Melanoma
  • Malignant Peritoneal Neoplasm
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Ovarian Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Through completion, average of 1 year

Year 1
Safety and tolerability of single-agent ZN-c3, including identification of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), based on the incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable participants.
Through completion
Dose Escalation, Food Effect cohort & Dose Expansion
Food Effect Cohort
Year 1
Preliminary estimates of antitumor efficacy of single agent ZN-c3
Safety and tolerability of single-agent ZN-c3, including identification of the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), based on the incidence and severity of adverse events (AEs).
Month 43
Dose Expansion
Month 43
Clinical activity of WEE1 inhibition by ZN-c3 at RP2D in subjects with uterine serous carcinoma.
Year 1
Dose Escalation
Through completion...
Dose Escalation, Food Effect cohort and Dose Expansion

Trial Safety

Phase-Based Safety

1 of 3

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1
XL092
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Single Agent Dose Escalation
1 of 4
Single Agent Food Effect Cohort
1 of 4
Single Agent Dose Expansion
1 of 4
Single Agent Dose Escalation and Expansion
1 of 4

Experimental Treatment

146 Total Participants · 4 Treatment Groups

Primary Treatment: ZN-c3 · No Placebo Group · Phase 1

Single Agent Dose Escalation
Drug
Experimental Group · 1 Intervention: ZN-c3 · Intervention Types: Drug
Single Agent Food Effect Cohort
Drug
Experimental Group · 1 Intervention: ZN-c3 · Intervention Types: Drug
Single Agent Dose Expansion
Drug
Experimental Group · 1 Intervention: ZN-c3 · Intervention Types: Drug
Single Agent Dose Escalation and Expansion
Drug
Experimental Group · 1 Intervention: ZN-c3 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through completion, average of 1 year

Who is running the clinical trial?

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
6 Previous Clinical Trials
644 Total Patients Enrolled
K-Group BetaLead Sponsor
5 Previous Clinical Trials
562 Total Patients Enrolled
Philippe Pultar, MDStudy DirectorK-Group Beta, a Zentalis Company
2 Previous Clinical Trials
484 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are participants still able to apply for this research endeavor?

"Clinicaltrials.gov confirms that this ongoing investigation is still seeking participants; the study was first made public on November 1st 2019 and most recently revised on August 12th 2021." - Anonymous Online Contributor

Unverified Answer

What is the current rate of enrollment in this study?

"K-Group Beta is the study sponsor, and they are recruiting 110 participants who meet all inclusion criteria between their two sites in Detroit, Michigan (Site 0101) and San Antonio, Texas (Site 0100)." - Anonymous Online Contributor

Unverified Answer

Has ZN-c3 been sanctioned by the Federal Drug Administration as a safe and effective therapeutic option?

"Because this is an early-stage trial, ZN-c3 received a score of 1 due to the limited evidence surrounding its safety and efficacy." - Anonymous Online Contributor

Unverified Answer

In which areas can this research take place?

"Currently, the investigation is being conducted in 4 distinct areas. These sites are based in Detroit, San Antonio and Houston as well as other cities with additional centres. It may be useful to select a clinic that is nearest your abode so you can limit time spent travelling for trial purposes if participants decide to partake." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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