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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have confirmed ovarian high-grade serous carcinoma (histologically or cytologically)

‣ Participants should have platinum resistance

⁃ No PLD use after developing platinum resistance

⁃ Participants must have had bevacizumab in a prior treatment line or must have been ineligible for bevacizumab therapy.

• ECOG status 0-1

• Measurable disease per RECIST v1.1 as assessed by local site Investigator/radiologists in the Dose Escalation phase, and assessed by BICR in the Dose Optimization phase and Phase 3; lesions situated in previous irradiated areas are considered measurable if progression has been demonstrated in such lesions

• Left ventricular ejection fraction \> 50%

• Participants with adequate hematologic function based on following

‣ Absolute neutrophil count ≥ 1.5 × 109/L

⁃ Platelet count ≥ 100 × 109/L

⁃ Hemoglobin ≥ 9.0 g/dL

⁃ Albumin ≥ 3.0 g/dL

• Adequate coagulation parameters based on the following:

‣ Prothrombin time-internationalization normal rate (INR)/partial thromboplastin time \< 1.5 × upper limit of normal (ULN)

⁃ Partial thromboplastin time or activated partial thromboplastin time \< 1.25 × ULN

• Participants must have adequate hepatic and renal function. For hepatic function, total bilirubin should be less than 1.5 times the ULN. For renal function, serum creatinine clearance must be at least 45 mL/min.

• Participants of childbearing potential (defined as sexually mature women who have not undergone surgical sterilization or been postmenopausal for at least 12 months if over 55 years of age) must have a negative pregnancy test within 72 hours before starting treatment. These participants must use highly effective contraception or abstain from heterosexual activity from screening through 120 days after the last dose of study medication.

Locations
United States
Arizona
HonorHealth Cancer Care
RECRUITING
Phoenix
Louisiana
Trials365
RECRUITING
Shreveport
Pennsylvania
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Wisconsin
University Of Wisconsin Carbone Cancer Center
RECRUITING
Madison
Contact Information
Primary
EVP Clinical Operation and Quality Assurance
clinicaltrials@novita-pharm.com
312-877-2533
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2029-10-24
Participants
Target number of participants: 380
Treatments
Experimental: Part A1 (Dose escalation):NP-G2-044 Monotherapy
Participants will receive multiple doses of NP-G2-044 in tablet form orally as a monotherapy twice a daily.
Experimental: Part A2 (Dose escalation): NP-G2-044+PLD combination therapy
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.
Experimental: Part B (Dose optimization): NP-G2-044+PLD combination dose level 1
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.
Experimental: Part B (Dose optimization): NP-G2-044+PLD combination dose level 2
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.
Active_comparator: Part B (Dose optimization) :PLD
Participants will receive a single dose of PLD as an infusion via intravenous route alone once in every 28 days.
Experimental: Part C (Phase 3): NP-G2-044+PLD
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.
Active_comparator: Part C (Phase 3): PLD
Participants will receive a single dose of PLD as an infusion via intravenous route once in every 28 days.
Related Therapeutic Areas
Sponsors
Leads: Novita Pharmaceuticals, Inc.
Collaborators: Gynecologic Oncology Group

This content was sourced from clinicaltrials.gov

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