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Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)

NCT07109414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-03-09

No results posted yet for this study

Summary

The purpose of the study is to identify the optimal dose level of NP-G2-044 in combination with standard of care (SOC) pegylated liposomal doxorubicin (PLD), and to compare the efficacy and safety of NP-G2-044+PLD vs. PLD alone in participants with platinum-resistant ovarian cancer (PROC).

Conditions

Interventions

DRUG

NP-G2-044

NP-G2-044 will be provided as a tablet via oral route of administration in the study.

DRUG

PLD

PLD will be provided as an infusion via intravenous route of administration in the study.

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • Novita Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jillian Zhang, PhD · Novita Pharmaceuticals, Inc.

  • Lisa Barroilhet, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2028-10-25
Completion
2029-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07109414 on ClinicalTrials.gov