ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors

NCT06161493 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-10-15

No results posted yet for this study

Summary

This Phase I, open label, dose determining study of oral niraparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with metastatic or recurrent solid cancer. Dose escalation will follow the mTPI-2/Keyboard design. Eligible patients will receive therapy until disease progression or unacceptable toxicities are experienced.

Conditions

Interventions

DRUG

ZEN003694

A bromodomain extra-terminal inhibitor (BETi) that blocks a group of proteins called bromodomain and extra-terminal (BET), which may counteract the effect of NSD3 on tumor growth.

DRUG

Niraparib

An anti-cancer medication (PARP inhibitor) used for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer .

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Zenith Epigenetics

    collaborator INDUSTRY
  • Haider Mahdi

    lead OTHER

Principal Investigators

  • Haider S Mahdi, MD · UPMC Magee Women's Hospital, UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2026-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161493 on ClinicalTrials.gov