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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug called SNK01 in combination with another cancer drug called AFM24. The trial is being done to see if the new drug is safe and effective against cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is advanced or has spread, and tests show it has EGFR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Phase 1/Dose Escalation
Phase 2a/Expansion
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
Find a Location
Who is running the clinical trial?
NKGen Biotech, Inc.Lead Sponsor
6 Previous Clinical Trials
88 Total Patients Enrolled
Affimed GmbHIndustry Sponsor
10 Previous Clinical Trials
659 Total Patients Enrolled
Steven S. Cha, MDStudy DirectorNKGen Biotech, Inc.
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe lung, thyroid, kidney, or liver diseases that could make this study unsafe for me.My cancer is EGFR-positive and standard treatments no longer work for me.I am on medication for an autoimmune disease or have a condition that weakens my immune system.I am 18 years old or older.I cannot receive fluids through IV due to a condition in my chest.I have brain metastases that are either untreated or causing symptoms.I am fully active or restricted in physically strenuous activity but can do light work.My side effects from previous cancer treatments are mild, except for nerve issues, low lymphocyte count, or hair loss.I haven't had cancer treatment or been part of a device trial in the last 4 to 6 weeks.I have a serious heart condition.I have not had major surgery in the last 4 weeks.I haven't had a serious infection needing treatment in the last 2 weeks.You have tested positive for HIV, Hepatitis B, or Hepatitis C.I am able to understand and sign the consent form.You have at least one tumor that can be measured according to specific guidelines.My cancer is advanced or has spread, and tests show it has EGFR.My disease history matches the specific conditions listed.I haven't had radiation in the last 2 weeks or have lingering side effects.My liver, kidneys, and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2a, Expansion Cohort 3 - Non-small cell lung cancer (EXP-3: NSCLC)
- Group 2: Phase 1, Dose Escalation
- Group 3: Phase 2a, Expansion Cohort 1 - Metastatic colorectal cancer (EXP-1: mCRC)
- Group 4: Phase 2a, Expansion Cohort 2 - Head and Neck Squamous Cell Carcinoma (EXP-2: SCCHN)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity for participants in this medical experiment?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was first launched on November 3rd 2021, is currently recruiting patients. The team seeks to enroll 121 people at a single medical facility."
Answered by AI
Are any new participants being accepted for this research project?
"As indicated by the information on clinicaltrials.gov, this trial is currently procuring participants, with its initial posting dating back to November 3rd 2021 and its most recent update occurring January 26th 2022."
Answered by AI
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