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Platinum-resistant Ovarian CancerPhase 2/3NCT07109414

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

A Phase 2/3 study testing NP-G2-044 and PLD in people with Platinum-resistant Ovarian Cancer, run by Novita Pharmaceuticals, Inc. at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
NP-G2-044 and PLD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
6 sitesUnited States
Study dates
29 Dec 2025to 24 Oct 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Primary platinum-refractory (recurrence within 120 days of first-line platinum-containing therapy or during first-line platinum-containing therapy).
  • Recurrence greater than 183 days from the penultimate platinum (platinum-sensitive recurrent ovarian cancer).
  • Uncontrolled malignant pleural effusions and/or ascites as defined by a prior needle drainage within 60 days of first dose.
  • Major surgery within 4 weeks prior to Screening.
  • Prior radiotherapy within 4 weeks of start of study treatment.
  • Participants must have recovered from all radiation-related toxicities, not require corticosteroids for their radiation therapy, and have no history of radiation pneumonitis.
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  • A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • Anticancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents prior to administration of the first dose of study treatment.
  • Active CNS metastases; participants with leptomeningeal metastases are not eligible.
  • Primary CNS malignancy.
  • Severe gastrointestinal conditions such as existing bowel obstruction defined as air fluid levels in the small bowel and/or intolerance to oral medications, clinical or radiological evidence of bowel obstruction within 8 weeks prior to study entry requiring hospitalization, current use of nasogastric tube decompression, inability to tolerate solid feedings or vomiting more than once a day.
  • Liver metastases involving > 60% of liver parenchyma.
  • Known active infection with Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C virus (HCV)
  • Requiring immunosuppressive therapy
  • Evidence of ongoing systemic bacterial, fungal, or viral infections at Screening
  • Received a live vaccine within 6 weeks of first dose of study drug.
  • Received a Coronavirus disease-2019 (COVID-19) vaccine less than 1 week prior to dosing (Cycle 1/Day 1) and/or during the study received a COVID-19 vaccine or booster less than 3 weeks ahead of a tumor assessment.
  • Baseline QT interval corrected with Fridericia's method (i.e., QTcF) > 470 ms.
  • Female participants who are pregnant or breastfeeding.
  • Concurrent active malignancy.
  • History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment.
  • History of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA classification III or IV), clinically significant left ventricular hypertrophy or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening.
  • Participants with increased baseline risk of Torsades de Pointe due to:
  • Electrolyte imbalance at screening (clinically significant hypokalemia, hypomagnesemia or hypocalcemia per Investigator's determination)
  • Known congenital long QT syndrome (LTQS)
  • Bradycardia (heart rate < 50 beats per minute)
  • Unstable or severe uncontrolled medical condition like unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes or any important medical illness or abnormal laboratory findings
  • Grade 3 or 4 toxicity due to PLD in prior treatment.
  • Grade 2 or greater neuropathy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Optimum Clinical Research Group, LLC

    Albuquerque, New Mexico, 87109

  • University Of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792-9988

  • University of Pennsylvania Health System, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104-5127

  • HonorHealth Cancer Care

    Phoenix, Arizona, 85016

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Trials365

    Shreveport, Louisiana, 71133

Other trials in United States

About this study

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

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).

Read the detailed description

This is an open-label, Phase 2/3, multicenter, randomized study of NP-G2-044 in combination with PLD vs. PLD alone in participants with PROC. The Phase 2 component of the study includes a safety lead-in dose escalation of NP-G2-044 monotherapy with twice daily (BID) dosing and a dose escalation phase for NP-G2-044+PLD followed by a randomized dose optimization phase of NP-G2-044+PLD compared with PLD. In the Phase 3 component of the study, participants will be randomized to treatment with NP-G2-044+PLD, at the dose selected from the dose optimization phase, or to PLD alone. Randomized participants will be stratified according to the number of prior lines of therapy, number of prior PLD therapy lines, and region of the world. The study population is women at least 18 years of age with confirmed ovarian high grade serous carcinoma, an Eastern Cooperative Oncology Group (ECOG) status of 0-1, and whose cancer is resistant to platinum-based therapy.

Being tested
NP-G2-044, PLD
Keywords
Dose escalation, Dose optimization, Small-molecule fascin inhibitor, Advanced or metastatic ovarian cancer, Randomized Phase 3
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NP-G2-044Drug

    Also called Prilukae

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

  • PLDDrug

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

Study groups in NCT07109414
Study groupRoleWhat they receive
Part A1 (Dose escalation):NP-G2-044 MonotherapyExperimentalParticipants will receive multiple doses of NP-G2-044 in tablet form orally as a monotherapy twice a daily.
Receives: Drug: NP-G2-044
Part A2 (Dose escalation): NP-G2-044+PLD combination therapyExperimentalParticipants 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.
Receives: Drug: NP-G2-044; Drug: PLD
Part B (Dose optimization): NP-G2-044+PLD combination dose level 1ExperimentalParticipants 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.
Receives: Drug: NP-G2-044; Drug: PLD
Part B (Dose optimization): NP-G2-044+PLD combination dose level 2ExperimentalParticipants 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.
Receives: Drug: NP-G2-044; Drug: PLD
Part B (Dose optimization) :PLDActive comparatorParticipants will receive a single dose of PLD as an infusion via intravenous route alone once in every 28 days.
Receives: Drug: PLD
Part C (Phase 3): NP-G2-044+PLDExperimentalParticipants 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.
Receives: Drug: NP-G2-044; Drug: PLD
Part C (Phase 3): PLDActive comparatorParticipants will receive a single dose of PLD as an infusion via intravenous route once in every 28 days.
Receives: Drug: PLD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A (Dose escalation): Number of participants with adverse events (AEs)

    The safety and tolerability of NP-G2-044 monotherapy with BID dosing and in combination with PLD will be evaluated

    Measured: From first dose until Safety Follow-up (30 days ±7 days after last dose of NP-G2-044) Approximately 2 years

  2. Part A (Dose escalation): Number of participants with Dose Limiting Toxicities (DLTs)

    The safety and tolerability of NP-G2-044 monotherapy with BID dosing and in combination with PLD and to determine the recommended Phase 2 dose (RP2D) of NP-G2-044 when combined with PLD will be determined

    Measured: Up to 28 days

  3. Part B (Dose Optimization): Number of participants with AEs

    The safety and tolerability of the treatment groups will be compared.

    Measured: From Day 1 until Safety Follow-up (30 days ±7 days after last dose of NP-G2-044) Approximately 2 years

  4. Part B (Dose Optimization): Overall response rate (ORR)

    The optimal dose of NP-G2-044 combined with PLD will be evaluated. The ORR is defined as the proportion of participants with complete response (CR) or partial response (PR).

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (Approximately 2 years)

  5. Part B (Dose Optimization): Progression free survival (PFS)

    The optimal dose of NP-G2-044 combined with PLD will be evaluated. The PFS is defined as time from randomization until adequately documented disease progression based on blinded independent committee review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever occurs first.

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (Approximately 2 years)

  6. Part C (Phase 3): Progression free survival (PFS)

    The efficacy of NP-G2-044 when combined with PLD vs. PLD alone will be compared. The PFS is defined as time from randomization until adequately documented disease progression based on BICR per RECIST v1.1 or death, whichever occurs first.

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (Approximately 3 years

Secondary outcomes (15)

  1. Part A (Dose Escalation) and Part C (Phase 3): Overall response rate (ORR)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The ORR is defined as the proportion of participants with CR or PR.

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (For Part A: Approximately 2 years; Part C: Approximately 3 years)

  2. Part A (Dose Escalation): Progression free survival (PFS)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The PFS is defined as time from start of treatment until adequately documented disease progression based on local assessment of imaging studies, or death, whichever occurs first.

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (For Part A: Approximately 2 years; Part C: Approximately 3 years)

  3. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Gynecologic Cancer Intergroup Cancer antigen-125 (GCIG CA-125) criteria for response

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Participants can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment. The date when the CA-125 level is first reduced by 50% is the date of the CA-125 response. To calculate CA-125 responses accurately, the following rules apply: 1) Intervening samples and the 28-day confirmatory sample must be less than or equal to (within an assay variability of 10%) the previous sample. 2) Variations within the normal range of CA-125 levels will not interfere with the response definition.

    Measured: From Screening to survival follow-up (until progression, death, or withdrawal of consent) (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  4. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Overall survival (OS)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The OS is defined as time from start of treatment until death.

    Measured: From randomization until death For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  5. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Disease control rate (DCR)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The DCR is defined as the proportion of participants with confirmed CR, PR or stable disease (SD).

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  6. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Duration of response (DOR)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The DoR is defined as the time from first CR or PR to disease progression or death in participants who achieve CR or PR.

    Measured: From randomization until disease progression, death, or withdrawal of consent, whichever occurs first (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  7. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Metastasis-free interval (MFI)

    The initial efficacy of NP-G2-044 in combination with PLD will be evaluated. The MFI is defined as the time from start of treatment to confirmed occurrence of new metastasis.

    Measured: From treatment initiation to confirmed occurrence of new metastasis (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  8. Part A (Dose Escalation) and Part C (Phase 3): Number of participants with AEs

    The safety and the tolerability of the treatment groups will be compared.

    Measured: From Day 1 until Safety Follow-up (30 days ±7 days after last dose of NP-G2-044) For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  9. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Participant reported outcomes based on European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28)

    The treatment groups for participant reported Quality of life (QoL) will be compared. The EORTC QLQ-OV28 will evaluate the QoL with respect to ovarian cancer. The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden.

    Measured: At screening, every 3 cycles starting Cycle 1 Day 1 (each Cyle is 28 days) For Part A and B: (Approximately 2 years; Part C: Approximately 3 years)

  10. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Participant reported outcomes based on European Quality of Life -5 Dimensions -5 Levels (EuroQol EQ-5D-5L)

    The treatment groups for participant reported QoL will be compared. The EQ-5D-5L questionnaire assess health outcome from a wide variety of interventions on a common scale. It is comprised of 5 dimensions where each dimension has 5 levels. A higher score represents a worse outcome.

    Measured: At screening, every 3 cycles starting Cycle 1 Day 1 (each Cyle is 28 days) (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  11. Part A (Dose Escalation), Part B (Dose optimization) and Part C (Phase 3): Participant reported outcomes based on Functional Assessment of Cancer Therapy Ovarian Symptom Index (FOSI)

    The treatment groups for participant reported QoL will be compared. The FOSI 8-item questionnaire measures response to treatment based on symptom assessment. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).

    Measured: At screening, every 3 cycles starting Cycle 1 Day 1 (each Cyle is 28 days) (For Part A and B: Approximately 2 years; Part C: Approximately 3 years)

  12. Part A (Dose Escalation) and Part B (Dose optimization): Terminal half-life (T1/2) of NP-G2-044 and PLD

    The T1/2 of NP-G2-044 as a monotherapy with BID dosing and NP-G2-044 and PLD as combination therapy will be evaluated.

    Measured: From Day 1 to End of treatment (Approximately 2 years)

  13. Part A (Dose Escalation) and Part B (Dose optimization): Time to maximum plasma concentration (Tmax) of NP-G2-044 and PLD

    The Tmax of NP-G2-044 as a monotherapy with BID dosing and NP-G2-044 and PLD as combination therapy will be evaluated.

    Measured: From Day 1 to End of treatment (Approximately 2 years)

  14. Part A (Dose Escalation) and Part B (Dose optimization): Maximum plasma concentration (Cmax) of NP-G2-044 and PLD

    The Cmax of NP-G2-044 as a monotherapy with BID dosing and NP-G2-044 and PLD as combination therapy will be evaluated.

    Measured: From Day 1 to End of treatment (Approximately 2 years)

  15. Part A (Dose Escalation) and Part B (Dose optimization): Area under the plasma concentration-time curve (AUC) of NP-G2-044 and PLD

    The AUC of NP-G2-044 as a monotherapy with BID dosing and NP-G2-044 and PLD as combination therapy will be evaluated.

    Measured: From Day 1 to End of treatment (Approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start29 Dec 2025
  3. Primary completion25 Oct 2028 (estimated)
  4. Study completion24 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109414
Sponsor's protocol ID
NP-G2-044-P3-01
Other IDs
GOG-3121
Status last verified
Mar 2026
First submitted
31 Jul 2025
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NP-G2-044 and PLD in people with Platinum-resistant Ovarian Cancer, run by Novita Pharmaceuticals, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A (Dose escalation): Number of participants with adverse events (AEs) (time frame: From first dose until Safety Follow-up (30 days ±7 days after last dose of NP-G2-044) Approximately 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07109414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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