Study on AFM24 and Atezolizumab for Advanced or Metastatic EGFR-Expressing Cancers

Sponsor: Affimed GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05109442

Provider View

This clinical trial is testing a new combination of drugs, AFM24 and atezolizumab, to see if they can help treat certain advanced cancers that express the EGFR protein and have not responded to previous treatments.

Patient Parameters

Program Overview

The study is exploring a new treatment using AFM24 and atezolizumab for patients with advanced cancers that express the EGFR protein. These cancers have progressed despite previous treatments. The trial is divided into two parts: the first part aims to find the best dose of the drug combination, and the second part will test how well the treatment works and confirm its safety.

Description

This study has two main parts: Phase 1 and Phase 2a.

In Phase 1, researchers will gradually increase the dose of AFM24 combined with atezolizumab to find the highest dose that patients can tolerate without severe side effects. Before starting the combination treatment, patients will receive a single dose of AFM24 and be monitored for any side effects for one week.

Once the best dose is determined, the study will move to Phase 2a. This phase will focus on gathering more information about how effective the treatment is and further confirming its safety.

The study will include patients with specific types of cancer, such as:

  • Non-small cell lung cancer (NSCLC) that has worsened after chemotherapy and PD1/PD-L1 therapy.
  • Gastric or gastroesophageal junction cancer that has not responded to standard chemotherapy.
  • Pancreatic, liver, or bile duct cancer that has progressed after standard treatments or when no suitable standard treatment is available.
  • Advanced NSCLC with specific EGFR mutations that have worsened after previous treatments, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic cancer that tests positive for EGFR, except for NSCLC.
  • Have advanced NSCLC that has worsened after at least one previous treatment, including a platinum-based chemotherapy and PD1/PD-L1 therapy.
  • Have advanced gastric or gastroesophageal cancer that has worsened after at least one chemotherapy regimen.
  • Have advanced liver, bile duct, or pancreatic cancer that has worsened after standard treatments or when no suitable standard treatment is available.
  • Have advanced NSCLC with specific EGFR mutations that have worsened after previous treatments, including a TKI for EGFR mutations.
  • Have adequate organ function.
  • For Phase 1: Have disease that can be evaluated or measured.
  • For Phase 2a: Have measurable disease.

Exclusion Criteria

  • Have received any systemic cancer treatment, including experimental drugs, within 4 weeks before starting the study drug.
  • Have received radiation therapy within 2 weeks before starting the study drug or have unresolved side effects from previous radiation.
  • Have another active cancer, except for certain early-stage cancers that have been treated and are not active.
  • Are currently participating in another clinical study or receiving another investigational drug.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.