NP-G2-044 + PLD for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with a specific type of ovarian cancer that no longer responds to platinum-based chemotherapy. The researchers aim to determine the optimal dose of a new drug, NP-G2-044, when combined with the standard drug, pegylated liposomal doxorubicin (PLD, a type of chemotherapy), and to evaluate the effectiveness of this combination compared to PLD alone. Individuals with ovarian cancer resistant to platinum treatments who have tried or cannot use bevacizumab might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have used certain cancer treatments recently, like chemotherapy or immunotherapy, before starting the trial. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that NP-G2-044 is generally safe and well-tolerated. Studies have found that using this treatment alone or with other therapies has not raised any major safety concerns. Patients have experienced only mild to moderate side effects.
Pegylated liposomal doxorubicin (PLD), when used with NP-G2-044, serves as a standard treatment for ovarian cancer. It has undergone thorough study and is considered safe. However, PLD can cause side effects like nausea or fatigue, which are common with many cancer treatments.
Overall, both NP-G2-044 and its combination with PLD have demonstrated promising safety results. This should provide reassurance about the safety of these treatments.12345Why are researchers excited about this trial's treatments?
NP-G2-044 is unique because it introduces a new approach to treating ovarian cancer by targeting specific pathways that are not the primary focus of most current treatments. Unlike standard care options like platinum-based chemotherapy, NP-G2-044 can be taken orally, making it potentially more convenient for patients. Additionally, when combined with PLD (pegylated liposomal doxorubicin), it optimizes treatment efficacy by potentially enhancing the drug's action while minimizing side effects. Researchers are excited about these treatments because they hold the promise of more effective management of ovarian cancer with improved patient quality of life.
What evidence suggests that this trial's treatments could be effective for platinum-resistant ovarian cancer?
Research has shown that NP-G2-044, a small molecule that blocks the protein fascin, can help prevent cancer from spreading and slow tumor growth. Early studies found that combining NP-G2-044 with standard cancer treatments led to positive responses in patients with advanced solid tumors. In this trial, participants in some arms will receive NP-G2-044 as a monotherapy or in combination with PLD. This combination has resulted in decreased tumor markers, with some patients experiencing at least a 50% reduction. For those with platinum-resistant ovarian cancer, this treatment could offer a new option if other therapies have failed. While the results are encouraging, researchers continue to test this combination therapy to ensure its effectiveness and safety.23467
Who Is on the Research Team?
Lisa Barroilhet, MD
Principal Investigator
University of Wisconsin, Madison
Jillian Zhang, PhD
Principal Investigator
Novita Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with platinum-resistant ovarian cancer who haven't used PLD after becoming resistant. They must have adequate blood cell counts, a healthy heart function (ejection fraction >50%), and an ECOG status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Prior bevacizumab treatment or ineligibility for it is also required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive NP-G2-044 monotherapy with BID dosing and NP-G2-044+PLD combination therapy to determine the recommended Phase 2 dose
Dose Optimization
Participants receive NP-G2-044+PLD combination therapy at optimized dose levels
Phase 3 Treatment
Participants are randomized to receive NP-G2-044+PLD or PLD alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NP-G2-044
- PLD
Trial Overview
The study aims to find the best dose of NP-G2-044 when combined with standard PLD therapy and to compare its effectiveness and safety against using just PLD alone in those with platinum-resistant ovarian cancer.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
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.
Participants will receive multiple doses of NP-G2-044 in tablet form orally as a monotherapy twice a daily.
Participants will receive a single dose of PLD as an infusion via intravenous route once in every 28 days.
Participants will receive a single dose of PLD as an infusion via intravenous route alone once in every 28 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novita Pharmaceuticals, Inc.
Lead Sponsor
Gynecologic Oncology Group
Collaborator
Citations
NCT07109414 | Trial of NP-G2-044 (Prilukae) Combined ...
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 ...
A phase 2 clinical trial of first-in-class fascin inhibitor NP- ...
NP-G2-044 is a novel, small molecule antagonist of fascin that blocks tumor metastasis, inhibits cancer growth and increases antigen uptake by intra-tumoral ...
3.
cancernetwork.com
cancernetwork.com/view/np-g2-044-elicits-durable-responses-tumor-control-in-advanced-solid-tumorsNP-G2-044 Elicits Durable Responses, Tumor Control in ...
Phase 2 study results revealed NP-G2-044 plus standard of care anti–PD-1 therapy indicated treatment exhibited responses across at least 7 ...
Novita Highlights Positive Data from Phase 2 Trial of NP- ...
Novita Highlights Positive Data from Phase 2 Trial of NP-G2-044 in Patients with Advanced and. Metastatic Solid Tumors at 2025 ASCO Annual ...
Novita Presents Additional Positive Data from Phase 2 Trial ...
The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and ...
NCT05023486 | NP-G2-044 as Monotherapy and ...
Multicenter, open-label study in patients with advanced or metastatic solid tumor malignancies to evaluate the safety, tolerability, and preliminary ...
7.
novita-pharm.com
novita-pharm.com/wp-content/uploads/2024/05/NP-G2-044-Novita-ASCO2024-Poster-FINAL.pdfPhase 2 Clinical Trial of First-in-Class Fascin Inhibitor NP- ...
... NP-G2-044 as Monotherapy and in Combination Therapy with anti-PD-1 ... The first-in-class fascin inhibitor, NP-G2-044, is safe and well tolerated.
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