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Monoclonal Antibodies

AFM24 + Atezolizumab for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Affimed GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed advanced or metastatic EGFR-positive selected cancer types: Advanced or metastatic NSCLC, EGFR WT: disease has progressed after ≥ 1 prior lines of therapy which must have included a platinum-based doublet in combination with PD1/PD-L1 antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet
Advanced, unresectable, or metastatic gastric/GEJ adenocarinoma: after ≥ 1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during cycle 1 (each cycle has 28 days)
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a drug called AFM24 with a drug called atezolizumab. The trial is open to people with certain types of advanced cancer who have tried other treatments that didn't work.

Who is the study for?
This trial is for adults with advanced or metastatic EGFR-positive cancers, like NSCLC, gastric/GEJ adenocarcinoma, HCC, hepatobiliary-, or pancreatic cancer that's worsened after treatment. They must have had certain prior therapies and good organ function. People can't join if they've had recent radiation therapy, active malignancies (with some exceptions), recent anticancer treatments, are using traditional Chinese medicine for tumors, or are in another clinical study.Check my eligibility
What is being tested?
The AFM24-102 study tests the combination of a new drug called AFM24 with an existing cancer medication Atezolizumab in patients with specific advanced solid tumors expressing EGFR. It's an open-label Phase 1/2a trial where all participants receive the drugs to evaluate safety and effectiveness at different doses.See study design
What are the potential side effects?
Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation of organs (like lungs or intestines), hormonal gland problems (like thyroid issues), liver problems and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is EGFR-positive and has worsened after treatment including platinum and PD1/PD-L1 therapy.
Select...
My stomach cancer is advanced and I've had at least one chemo treatment including platinum and fluoropyrimidine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during cycle 1 (each cycle has 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during cycle 1 (each cycle has 28 days) for reporting.

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
Frequency of patients developing anti-drug antibodies (ADAs) against AFM24
Incidence of TEAEs and SAEs
Pharmacokinetics (PK) of AFM24
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment2 Interventions
The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab.
Group II: Escalation PhaseExperimental Treatment2 Interventions
The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D.

Find a Location

Who is running the clinical trial?

Affimed GmbHLead Sponsor
10 Previous Clinical Trials
522 Total Patients Enrolled
Daniela Morales-Espinosa, MDStudy DirectorAffimed GmbH

Media Library

AFM24 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05109442 — Phase 1 & 2
Solid Tumors Research Study Groups: Escalation Phase, Expansion Phase
Solid Tumors Clinical Trial 2023: AFM24 Highlights & Side Effects. Trial Name: NCT05109442 — Phase 1 & 2
AFM24 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05109442 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural clinical trial of its kind?

"AFM24 has been researched since 2008 and the initial trial was funded by Hoffmann-La Roche. Subsequent to this, Phase 2 drug approval for AFM24 was granted after 720 had participated in trials. Currently, 351 active studies of AFM24 are being conducted across 1646 cities and 74 countries around the globe."

Answered by AI

Are there still open opportunities to participate in this clinical experiment?

"Affirmative; according to the clinicaltrials.gov portal, this medical experiment is still searching for participants, who first posted an advertisement on November 19th 2021 and last modified it on September 30th 2022. 105 patients must be enrolled from 3 separate locations."

Answered by AI

What is the intended outcome of this clinical research project?

"This medical trial aims to monitor and measure the dose-limiting toxicities (DLT) during the initial stage. Secondary objectives include tracking treatment-emergent adverse events (TEAEs) or serious adverse effects (SAEs). The investigators will assess clinical benefit rate, overall response rate and evaluate results over a 36 week time frame using RECIST v1.1 criteria."

Answered by AI

Could you provide a synopsis of the prior research conducted on AFM24?

"AFM24 was initially investigated in 2008 at SCRI Tennessee Oncology Chattanooga. To date, 80 trials have been concluded and currently there are 351 experiments actively recruiting participants, with a substantial amount of these studies taking place within Los Angeles."

Answered by AI

What is the current number of participants in this clinical experiment?

"Affirmative. The information available on clinicaltrials.gov confirms that this medical trial is actively recruiting candidates; it was initially published on November 19th 2021 and most recently updated on September 30th 2022. 105 participants must be enrolled across 3 sites for the study to progress as planned."

Answered by AI

What medical conditions can AFM24 be used to alleviate?

"AFM24 has shown efficacy in the treatment of small cell lung cancer (SCLC), postoperative care, and various malignant neoplasms including non-small cell lung carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
2021. "Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05109442.
~22 spots leftby Sep 2024
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