What side effects are associated with this type of intervention?

Common side effects of immune checkpoint inhibitors, such as pembrolizumab and nivolumab, used in the treatment of solid tumor malignancies include fatigue, diarrhea, rash, pruritus, and pneumonitis. Severe adverse events can include grade 3 or 4 toxicities like pneumonia and colitis. These treatments can also lead to immune-related adverse events requiring systemic immunosuppression, which may impact overall survival.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumor malignancies that enhance the immune response against tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are PD-1 inhibitors. Pembrolizumab has been approved for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma. Nivolumab is also approved for similar indications, including melanoma and NSCLC. Additionally, combination therapies such as nivolumab with ipilimumab (a CTLA-4 inhibitor) have been approved for melanoma and renal cell carcinoma. These treatments work by blocking inhibitory pathways in T-cells, thereby enhancing the immune system's ability to attack tumors.

What other types of research exist?

Promising novel alternatives to NP-G2-044 for solid tumor malignancies include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 therapy that has shown efficacy in various solid tumors, including non-small cell lung cancer and renal cell carcinoma. 2) Atezolizumab (Tecentriq) - an anti-PD-L1 therapy used in combination with chemotherapy for non-small cell lung cancer and renal cell carcinoma. 3) Nivolumab (Opdivo) - an anti-PD-1 therapy effective in renal cell carcinoma and other solid tumors. 4) Combination therapies such as Atezolizumab plus Bevacizumab, which have shown promising results in renal cell carcinoma. These therapies have demonstrated significant clinical benefits and are considered effective options for enhancing immune response against tumors.

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Monoclonal Antibodies

NP-G2-044 Monotherapy/Combination for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Novita Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ and bone marrow function: ANC >1500 cells/μL, Hemoglobin >9.0 g/dL, Platelet count >100,000 cells/μL, Total bilirubin ≤1.5 mg/dL, Albumin ≥3.0 g/dL, Liver enzymes within normal range, Creatinine clearance ≥50 mL/min, Prothrombin time and partial thromboplastin time within normal range

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Unresolved toxicities from previous anti-cancer therapy above Grade 1

Ongoing immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NP-G2-044, which may work alone or with another drug that helps the immune system fight cancer. It targets patients with severe, spreading cancers. The new drug might stop tumor growth and help the body's defenses fight cancer more effectively.

Who is the study for?

Adults over 18 with advanced solid tumors, able to swallow pills and with good organ/bone marrow function. Women of childbearing age must test negative for pregnancy; men and women must use effective contraception. Excludes those with recent significant GI issues, brain metastases, heart problems, or who've had certain transplants or treatments recently.

What is being tested?

The trial is testing NP-G2-044 alone and combined with anti-PD-1 therapy in patients with advanced solid tumors. It aims to assess safety, tolerability, initial effectiveness against the tumor, how the body processes the drug (pharmacokinetics), and its action on the body (pharmacodynamics).

What are the potential side effects?

Potential side effects may include typical reactions from cancer therapies such as nausea, fatigue, immune-related effects due to anti-PD-1 therapy component which can cause inflammation in organs like lungs or intestines but specific side effect profile for NP-G2-044 will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, liver, and kidney functions are within normal ranges.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, confirmed by tissue analysis.

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I am a man who is either surgically sterile or willing to use strong contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have side effects from cancer treatment that are not severe.

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I am currently on medication to suppress my immune system.

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I do not have any unmanaged ongoing illnesses.

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I have had a stem cell or organ transplant in the past.

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I have brain metastases that haven't been treated or are unstable.

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I need medication that affects liver enzymes during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NP-G2-044 anti-tumor preliminary efficacy signals when administered as continuously dosed monotherapy assessed by RECIST 1.1

NP-G2-044 anti-tumor preliminary efficacy signals when administered in combination with anti-PD-1 therapy assessed by RECIST 1.1

Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 and anti-PD-1 combination therapy

+1 more

Secondary study objectives

Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-1 therapy

Combined Modality Therapy

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: NP-G2-044 Monotherapy - Capsule/TabletExperimental Treatment1 Intervention

NP-G2-044 capsule/tablet PO QD for each 28-day cycle

Group II: NP-G2-044 Combination Therapy With Anti-PD-1 TherapyExperimental Treatment2 Interventions

NP-G2-044 capsules PO QD for each 28-day cycle, Anti-PD-1 Therapy per standard of care, at a dose and frequency in accordance with the package insert

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumor malignancies include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells. Targeted therapy aims at specific molecules involved in cancer growth and progression, such as HER2 or VEGF, thereby minimizing damage to normal cells. Immunotherapy, which includes immune checkpoint inhibitors like anti-PD-1 or anti-CTLA-4 antibodies, enhances the body's immune response against cancer cells. This is particularly relevant for patients with solid tumors as it can lead to more effective and sustained tumor control by leveraging the body's natural defense mechanisms. NP-G2-044, being studied for its potential to enhance immune response, represents a promising approach in this category, potentially improving outcomes for patients with advanced or metastatic solid tumors.