What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as targeted therapies and immunotherapies, work by specifically attacking cancer cells or enhancing the body's immune response. Targeted therapies focus on specific genetic mutations or proteins in cancer cells, minimizing damage to normal cells. Immunotherapies boost the immune system's ability to recognize and destroy cancer cells. These approaches are important for patients with solid tumors as they provide more personalized and potentially more effective treatment options compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common side effects of targeted therapies and immunotherapies for advanced or metastatic solid tumors include immune-related adverse events such as skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), and respiratory problems (pneumonitis). Other notable side effects can include endocrine disorders (hypothyroidism), liver enzyme abnormalities, and fatigue. These adverse events vary in severity and may require management with immunosuppressive treatments like steroids.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapy agents for the treatment of advanced or metastatic solid tumors. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Similarly, nivolumab, another anti-PD-1 agent, has been approved for melanoma, renal cell carcinoma, and other cancers. Avelumab, an anti-PD-L1 antibody, is approved for Merkel cell carcinoma. Additionally, combination therapies like pembrolizumab plus lenvatinib have been approved for advanced endometrial cancer. These approvals highlight the growing role of immunotherapy and targeted treatments in managing advanced solid tumors.

What other types of research exist?

Promising alternatives to NC762 for the treatment of advanced or metastatic solid tumors in 2024 include: 1) Pembrolizumab, which has demonstrated efficacy in multiple solid tumors including non-small cell lung cancer and head and neck squamous cell carcinoma. 2) Nivolumab, which has shown positive outcomes in non-small cell lung cancer, renal cell carcinoma, and head and neck cancers. 3) Atezolizumab, effective in non-small cell lung cancer and renal cell carcinoma. 4) Combination therapies such as pembrolizumab with chemotherapy or nivolumab with ipilimumab, which have shown improved survival rates in various cancers.

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NC762 for Solid Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by NextCure, Inc.

Eligibility Criteria Checklist

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

Must have

Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent

ECOG performance status 0 to 1

Must not have

Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 7 days before the first administration of study drug

Documented known activating or driver mutations which have not been previously treated with a standard of care targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NC762 to see if it can help treat patients with advanced or metastatic solid tumors.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including breast, ovarian, and non-small cell lung cancer. Participants must have progressed after standard treatments or be unable to tolerate them. They should not be candidates for curative surgery and must agree to avoid pregnancy. People with certain blood disorders, untreated mutations, active infections, recent transfusions or immunotherapies are excluded.

What is being tested?

The study is testing NC762's safety and effectiveness in treating various advanced cancers. It involves multiple phases: initial dose escalation to determine safe levels followed by expansion to assess safety further and a phase focused on efficacy.

What are the potential side effects?

While specific side effects of NC762 aren't listed here, common ones from similar cancer drugs include fatigue, nausea, diarrhea, liver issues (like elevated enzymes), skin reactions at the injection site and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread and cannot be surgically removed with the aim of curing it.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I haven't received blood products or specific medications to stimulate blood cell production within the last 7 days.

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My cancer has a specific mutation that hasn't been treated with targeted therapy.

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I have a known history of HIV.

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My kidney function is below the normal range.

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I still have side effects from previous cancer treatments that are not mild.

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I have an infection that hasn't improved with treatment.

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My cancer has spread to my brain or its coverings.

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I have lung inflammation not caused by an infection or a history of lung disease.

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I do not have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 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

Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

Secondary study objectives

Area Under the Curve (AUC) of NC762

Disease Control Rate (DCR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Duration of Response (DoR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: 5mg/kg NC762Experimental Treatment1 Intervention

Subjects received NC762 IV at 5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Group II: 20mg/kg NC762Experimental Treatment1 Intervention

Subjects received NC762 IV at 20mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Group III: 10mg/kg NC762Experimental Treatment1 Intervention

Subjects received NC762 IV at 10mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Group IV: 1.5mg/kg NC762Experimental Treatment1 Intervention

Subjects received NC762 IV at 1.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

Group V: 0.5mg/kg NC762Experimental Treatment1 Intervention

Subjects received NC762 IV at 0.5mg/kg Q2W until disease progression, withdraw of consent, or intolerable toxicity (whichever comes first).

0 / 11Eligibility 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 tumors, such as targeted therapies and immunotherapies, work by specifically attacking cancer cells or enhancing the body's immune response. Targeted therapies focus on specific genetic mutations or proteins in cancer cells, minimizing damage to normal cells. Immunotherapies boost the immune system's ability to recognize and destroy cancer cells. These approaches are important for patients with solid tumors as they provide more personalized and potentially more effective treatment options compared to traditional chemotherapy.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.