What is the mechanism of action of this treatment?

Cancer treatments work through various mechanisms to target and destroy cancer cells. Immunotherapy, like NPX267, enhances the body's immune response against cancer by targeting specific proteins that help tumors evade immune detection. This is crucial for patients as it can lead to more effective and durable responses. Chemotherapy uses drugs to kill rapidly dividing cells, but it can also affect healthy cells, leading to side effects. Targeted therapy focuses on specific molecular targets associated with cancer, minimizing damage to normal cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, inhibiting their ability to reproduce. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the cancer type and individual patient factors.

What side effects are associated with this type of intervention?

Common side effects of immunotherapy treatments like NPX267, which target immune evasion in tumors, include fatigue, rash, diarrhea, and pruritus. More severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and myocarditis. These treatments can also cause immune-related adverse events that may require management with steroids or other immunosuppressive agents. Monitoring and managing these side effects are crucial to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs that target immune checkpoints to control immune evasion in tumors. Notable examples include pembrolizumab and nivolumab, which are PD-1 inhibitors, and ipilimumab, a CTLA-4 inhibitor. These drugs have been approved for various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Pembrolizumab and nivolumab work by blocking the PD-1 receptor, thereby enhancing the immune system's ability to attack cancer cells. Ipilimumab targets CTLA-4, another checkpoint protein, to boost immune response against tumors. These treatments are similar to NPX267, which targets the inhibitory receptor for B7-H7 (HHLA2) to control immune evasion in tumors.

What other types of research exist?

<ol> <li>CD74-targeted therapies: CD74 is a new candidate target for immunotherapy in B-cell neoplasms, showing potential when used alone or in combination with other antibodies like rituximab.</li> <li>E7777: A recombinant cytotoxic fusion protein targeting T-cell lymphomas, showing improved purity and efficacy over its predecessor, denileukin diftitox.</li> <li>PD-1/PD-L1 inhibitors: Agents like pembrolizumab and avelumab have shown promise in various cancers, including mesothelioma, by targeting the PD-1/PD-L1 pathway to enhance immune response against tumors.</li> <li>Nivolumab plus Ipilimumab: This combination has shown durable long-term responses in renal cell carcinoma and may offer a treatment-free interval, making it a promising option for patients seeking immunotherapy.</li> </ol>

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Monoclonal Antibodies

NPX267 for Cancer

Phase 1

Recruiting

Research Sponsored by NextPoint Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose through one year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NPX267, an antibody drug that helps the immune system fight cancer by targeting a specific marker on cancer cells. It focuses on patients with certain cancers, including a type of lung cancer, to find a safe and effective dose. The study will monitor side effects and check how well the drug works against tumors.

Who is the study for?

This trial is for adults with certain advanced cancers, like lung or breast cancer, that no longer respond to standard treatments. They must be fairly active (ECOG status 0 or 1), have normal organ function, and agree to use effective birth control. People can't join if they're on high-dose steroids for autoimmune diseases, have unstable brain tumors, severe lingering side effects from past cancer treatments (except hair loss or long-term nerve pain/skin color changes), or a history of serious immune-related lung/intestine problems.

What is being tested?

NPX267 is being tested in this study. It's an antibody drug given by IV every three weeks aimed at helping the body's immune system recognize and fight cancer cells expressing HHLA2 protein. The study will determine the right dose and assess how patients handle the treatment regarding safety and tolerability.

What are the potential side effects?

Potential side effects of NPX267 may include reactions related to strengthening the immune system against cancer which could affect various organs leading to inflammation-like symptoms; however, specific side effect profiles will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose through one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose through one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose through one year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of dose limiting toxicity

Incidence of treatment-emergent adverse events

Number of subjects with tumor response in tumors expressing B7-H7/HHLA2

Secondary study objectives

Area under the concentration curve (AUC) of NPX267

Half-life in circulation (T1/2) of NPX267

Immunogenicity of NPX267

+1 more

Other study objectives

Change in biomarkers of activity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NPX267 TreatmentExperimental Treatment1 Intervention

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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

Cancer treatments work through various mechanisms to target and destroy cancer cells. Immunotherapy, like NPX267, enhances the body's immune response against cancer by targeting specific proteins that help tumors evade immune detection. This is crucial for patients as it can lead to more effective and durable responses. Chemotherapy uses drugs to kill rapidly dividing cells, but it can also affect healthy cells, leading to side effects. Targeted therapy focuses on specific molecular targets associated with cancer, minimizing damage to normal cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, inhibiting their ability to reproduce. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the cancer type and individual patient factors.