Recruiting

NP-G2-044 and PLD for Platinum-Resistant Ovarian Cancer

What is being tested

NP-G2-044

+ PLD

Drug

Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years

+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2 & 3

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorNovita Pharmaceuticals, Inc.

Study ContactEVP Clinical Operation and Quality Assurance

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 29, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to find out if combining a new drug, NP-G2-044, with an existing treatment, PLD (pegylated liposomal doxorubicin), is more effective for treating ovarian cancer that no longer responds to standard platinum-based therapies. The study involves women aged 18 and older diagnosed with high-grade serous carcinoma of the ovary. This trial is important because it explores a potential new treatment option for patients whose cancer has become resistant, which can be a challenging stage to treat. Participants in the study will be randomly assigned to receive either the combination of NP-G2-044 and PLD or PLD alone. The study starts with a phase to determine safe dosing of NP-G2-044 alone and then in combination with PLD. In the later phase, the effectiveness of the combination treatment will be compared to PLD alone. The study evaluates outcomes based on factors such as the number of previous treatments the participants have had and their geographic location, ensuring a comprehensive understanding of how well the treatment works across different groups.

Official TitleRandomized Phase 2/3 Trial of NP-G2-044 (Prilukae) Combined With PLD for Treatment of Platinum-Resistant Ovarian Cancer (ULTIMUS-1)

NCT07109414

Principal SponsorNovita Pharmaceuticals, Inc.

Study ContactEVP Clinical Operation and Quality Assurance

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

380 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

8 inclusion criteria required to participate

Participants with adequate hematologic function based on following 1. Absolute neutrophil count ≥ 1.5 × 109/L 2. Platelet count ≥ 100 × 109/L 3. Hemoglobin ≥ 9.0 g/dL 4. Albumin ≥ 3.0 g/dL

ECOG status 0-1

Adequate coagulation parameters based on the following: 1. Prothrombin time-internationalization normal rate (INR)/partial thromboplastin time \< 1.5 × upper limit of normal (ULN) 2. Partial thromboplastin time or activated partial thromboplastin time \< 1.25 × ULN

Participants must have confirmed ovarian high-grade serous carcinoma (histologically or cytologically) 1. Participants should have platinum resistance 2. No PLD use after developing platinum resistance 3. Participants must have had bevacizumab in a prior treatment line or must have been ineligible for bevacizumab therapy.

Show More Criteria

24 exclusion criteria prevent from participating

Concurrent active malignancy.

Requiring immunosuppressive therapy

Primary CNS malignancy.

Liver metastases involving \> 60% of liver parenchyma.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive multiple doses of NP-G2-044 in tablet form orally as a monotherapy twice a daily.

Group II

Experimental

Participants will receive multiple doses of NP-G2-044 (once daily \[QD\] or BID) in tablet form orally plus a single dose of PLD as an infusion via intravenous route once in every 28 days. The recommended monotherapy doses of NP-G2-044 are determined from the results of Part A1.

Group III

Experimental

Participants will receive daily dose of NP-G2-044 in tablet form orally plus a single dose of PLD as an infusion via intravenous route once in every 28 days.

Group IV

Experimental

Participants will receive daily dose of NP-G2-044 in tablet form orally plus a single dose of PLD as an infusion via intravenous route once in every 28 days.

Group 5

Experimental

Participants will receive daily dose of NP-G2-044 in tablet form orally plus a single dose of PLD as an infusion via intravenous route once in every 28 days.

Group 6

Active Comparator

Participants will receive a single dose of PLD as an infusion via intravenous route alone once in every 28 days.

Group 7

Active Comparator

Participants will receive a single dose of PLD as an infusion via intravenous route once in every 28 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

HonorHealth Cancer Care

Phoenix, United StatesOpen HonorHealth Cancer Care in Google Maps

Recruiting

Trials365

Shreveport, United States

Recruiting

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, United States

Recruiting

Utah Cancer Specialists

Salt Lake City, United States

Recruiting

5 Study Centers