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Monoclonal Antibodies
AFM24 for Solid Cancers
Phase 1 & 2
Waitlist Available
Research Sponsored by Affimed GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase 1: Histologically or cytologically confirmed advanced or metastatic solid malignancies that are known to express EGFR
Phase 1: Patients must have at least one tumor site that is accessible to biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during cycle 1 (each cycle is 28 days)
Awards & highlights
Study Summary
This trial is testing a new cancer treatment called AFM24. It is a tetravalent bispecific antibody construct that targets EGFR-expressing solid tumors. The trial is open-label, non-randomized, and multi-center. It is testing multiple ascending doses of AFM24 to see if it is effective in treating advanced solid malignancies.
Who is the study for?
This trial is for adults with advanced solid tumors that express EGFR and have progressed after previous cancer treatments. They must have adequate organ function, no active secondary cancers (with some exceptions), and not be on recent anticancer therapies or another clinical study.Check my eligibility
What is being tested?
AFM24, a new antibody construct targeting EGFR-expressing tumors using the body's natural killer cells and macrophages, is being tested in patients who've had at least one line of prior cancer therapy. The study includes dose escalation/expansion phases to evaluate safety and effectiveness.See study design
What are the potential side effects?
As AFM24 is first in human testing, specific side effects are unknown but may include typical reactions related to immune system engagement such as fever, fatigue, allergic reactions, or potential tissue damage at tumor sites.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, spreads, and tests show it has EGFR.
Select...
I have a tumor that can be easily biopsied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during cycle 1 (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during cycle 1 (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1
Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR])
Secondary outcome measures
Disease Control rate (CR + PR +stable disease [SD])
Duration of Response Rate (DOR)
Incidence of patients who develop anti-drug antibodies (ADAs) and neutralizing ADAs during treatment with AFM24
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AFM24Experimental Treatment1 Intervention
Phase 1: Treatment of escalating doses of AFM24.
Phase 2a: Treatment of AFM24 at maximum tolerated dose/recommended phase 2 dose, stratified into cohorts by tumor type.
Find a Location
Who is running the clinical trial?
Affimed GmbHLead Sponsor
10 Previous Clinical Trials
585 Total Patients Enrolled
Andras Strassz, MDStudy DirectorAffimed GmbH
Michael Emig, MDStudy DirectorAffimed GmbH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, spreads, and tests show it has EGFR.I haven't had radiation therapy in the last 2 weeks or still have side effects from it.I've had cancer treatment before and my cancer got worse during or after treatment. No standard treatments are suitable for me now.I have a tumor that can be easily biopsied.I haven't had cancer treatment except for hormone therapy or radiotherapy in the last 4-6 weeks.I have no active cancers except for certain treated or non-threatening types.You are currently taking part in another study or have recently taken part in one involving experimental treatments or devices within the past 4 weeks.My organs are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: AFM24
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.
Are there any available slots for participants in this experiment?
"Affirmative. Clinicaltrials.gov reveals that this research trial is currently seeking participants, with the initial posting being on April 7th 2020 and the latest update occurring October 5th 2022. 155 individuals are required to be recruited from two distinct medical hubs."
Answered by AI
How many individuals are currently participating in this research endeavor?
"Affirmative. Per the information stored on clinicaltrials.gov, this research experiment is presently looking for volunteers; it was initially advertised on April 7th 2020 and most recently updated on October 5th 2022. A total of 155 participants will be selected from 2 different sites to partake in the study."
Answered by AI
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