What is the mechanism of action of this treatment?

Common treatments for colorectal cancer include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors (e.g., cetuximab), work by blocking the epidermal growth factor receptor, which is often overexpressed in colorectal cancer cells, thereby inhibiting their growth and survival. Immunotherapies, including NK cell therapies like SNK01, enhance the body's immune response against cancer cells. These treatments are significant for colorectal cancer patients as they offer more personalized and potentially effective options, especially for those with specific genetic mutations or who are resistant to conventional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as cetuximab (an EGFR-targeting monoclonal antibody), are associated with several side effects. These include skin toxicity (such as rash), diarrhea, hypertension, anorexia, and mucositis/stomatitis. The addition of cetuximab to chemotherapy can also increase the incidence of severe adverse events like hypomagnesemia, severe skin reactions, and sepsis. While specific data on NK cell therapy (SNK01) and EGFR-targeting bispecific antibodies (AFM24) are limited, they may share similar side effect profiles given their mechanisms of action.

What prior FDA approvals exist?

FDA-approved treatments for colorectal cancer include targeted therapies and immunotherapies. Cetuximab and panitumumab are monoclonal antibodies targeting the EGFR, used in patients with metastatic colorectal cancer. These agents are similar to AFM24, an EGFR-targeting bispecific antibody. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab have been approved for colorectal cancer with specific genetic markers such as dMMR/MSI-H. While NK cell therapies like SNK01 are still under investigation, these approved treatments reflect the ongoing development of targeted and immune-based therapies for colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: <ol> <li>Capecitabine plus Bevacizumab: This combination has shown a high tumor control rate (88%) and a median progression-free survival (PFS) of 23.4 months in a phase II trial.</li> <li>Irinotecan-based Regimens: These regimens are effective for patients who can tolerate continuous treatment, as they do not have cumulative dose-dependent toxicities.</li> <li>EGFR Inhibitors (Cetuximab or Panitumumab): Maintenance therapy with these agents, especially in combination with fluorouracil, has shown benefits in patients with wild-type RAS tumors.</li> <li>Lenvatinib: Demonstrated modest antitumor activity with a median PFS of 15.9 months in a phase II trial for gastrointestinal neuroendocrine tumors (GINETs).</li> </ol>

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Monoclonal Antibodies

AFM24 + SNK01 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by NKGen Biotech, Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically confirmed advanced or metastatic EGFR positive malignancy of mCRC (EXP-1 cohort), SCCHN (EXP-2 cohort) or NSCLC (EXP-3 cohort)

Must not have

No resolution of specific toxicities related to any prior anti-cancer therapy to Grade ≤ 1 according to the NCI-CTCAE v.5.0 (except peripheral or motor neuropathy, lymphopenia and alopecia)

Radiation therapy within 2 weeks before first dose of any study treatment or unresolved (NCI CTCAE v5.0 Grade > 1) toxicity from previous radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of combining two treatments, SNK01 and AFM24, in patients with advanced cancers that have a specific protein called EGFR. The goal is to see if these treatments can help the immune system better recognize and destroy cancer cells. The study will first determine safe dosage levels and then evaluate how well the combination works.

Who is the study for?

Adults with advanced or metastatic cancers that express EGFR and have exhausted standard treatments can join. They must be in relatively good health (ECOG 0-1), able to consent, and have at least one measurable tumor. Excluded are those with autoimmune diseases needing treatment, severe medical conditions, recent major surgery, untreated brain metastases, uncontrolled infections, or positive tests for HIV/HBV/HCV.

What is being tested?

The trial is testing the combination of two drugs: AFM24 and SNK01 on patients with specific types of cancer expressing a protein called EGFR. It's an open-label study meaning everyone knows what treatment they're getting; it aims to see how safe the drug combo is and if it shrinks tumors.

What are the potential side effects?

While not specified here, similar cancer treatments often cause fatigue, nausea, skin reactions at injection sites, immune-related effects like inflammation in organs or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced or has spread, and tests show it has EGFR.

Exclusion Criteria

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

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My side effects from previous cancer treatments are mild, except for nerve issues, low lymphocyte count, or hair loss.

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I haven't had radiation in the last 2 weeks or have lingering side effects.

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I have a serious heart condition.

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I am on medication for an autoimmune disease or have a condition that weakens my immune system.

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I cannot receive fluids through IV due to a condition in my chest.

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I have brain metastases that are either untreated or causing symptoms.

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I haven't had cancer treatment or been part of a device trial in the last 4 to 6 weeks.

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I have not had major surgery in the last 4 weeks.

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I haven't had a serious infection needing treatment in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

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

Treatment Details

Study Objectives

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

Secondary study objectives

Phase 1/Dose Escalation

Phase 2a/Expansion

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC)Experimental Treatment2 Interventions

SNK01 (fixed dose) will be administered weekly by IV infusion.

Group II: Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN)Experimental Treatment2 Interventions

SNK01 (fixed dose) will be administered weekly by IV infusion.

Group III: Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC)Experimental Treatment2 Interventions

SNK01 (fixed dose) will be administered weekly by IV infusion.

Group IV: Phase 1, Dose EscalationExperimental Treatment2 Interventions

It is estimated that approximately 3-6 subjects will be enrolled per cohort in three dose cohorts for a total of 12-18 participants. SNK01 (fixed dose) will be administered weekly by IV infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SNK01

2019

Completed Phase 1

~30

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 colorectal cancer include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors (e.g., cetuximab), work by blocking the epidermal growth factor receptor, which is often overexpressed in colorectal cancer cells, thereby inhibiting their growth and survival. Immunotherapies, including NK cell therapies like SNK01, enhance the body's immune response against cancer cells. These treatments are significant for colorectal cancer patients as they offer more personalized and potentially effective options, especially for those with specific genetic mutations or who are resistant to conventional chemotherapy.