Trial results for the Phase 1/2a study investigating atezolizumab in combination with AFM24 for selected advanced/metastatic EGFR-expressing cancers were posted on ClinicalTrials.gov on 2025-08-20. The study was officially terminated, having enrolled 112 participants. Key findings included 0 and 1 participant experiencing dose-limiting toxicities (DLTs) in Phase 1 cohorts, and 1 to 8 participants achieving an overall response rate in various Phase 2a expansion cohorts.
Background
The study, titled "Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers," was an open-label, non-randomized, multicenter trial. It evaluated AFM24 in combination with atezolizumab in patients with selected EGFR-expressing advanced solid malignancies whose disease had progressed after previous anticancer therapies.
Trial design
The study (NCT05109442) was a Phase 1/2a, open-label, non-randomized, multicenter trial with an enrollment of 112 participants. It investigated the combination of AFM24 and atezolizumab 840 mg in 14 ml injection in patients with advanced solid tumor, specifically selected EGFR-expressing advanced solid malignancies. The study included dose escalation and expansion phases.
Key results
The trial reported the following key measurements:
- Phase 1: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1
- Phase 1 - Cohort 1 (AFM24 160 mg + Atezolizumab 840 mg): 0 Participants
- Phase 1 - Cohort 2 (AFM24 480 mg + Atezolizumab 840 mg): 1 Participant
- Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR])
- Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg: 8 Participants
- Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg: 1 Participant
- Phase 2 - Coh. EXP-3 (Hepatocellular, Hepatobiliary, Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg: 1 Participant
- Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg: 4 Participants
- Incidence of Patients With TEAEs
- Phase 1 - Cohort 1 - AFM24 160 mg + Atezolizumab 840 mg: 4 Participants
- Phase 1 - Cohort 2 - AFM24 480 mg + Atezolizumab 840 mg: 6 Participants
- Phase 2 - Coh. EXP-1 (EGFR-WT NSCLC) - AFM24 480 mg + Atezolizumab 840 mg: 49 Participants
- Phase 2 - Coh. EXP-2 (Gastric or GEJ Adenocarcinoma) - AFM24 480 mg + Atezolizumab 840 mg: 11 Participants
- Phase 2 - Coh. EXP-3 (Hepatocellular, Hepatobiliary, Pancreatic) - AFM24 480 mg + Atezolizumab 840 mg: 11 Participants
- Phase 2 - Coh. EXP-4 (EGFR Kinase Domain Mutation NSCLC) - AFM24 480 mg + Atezolizumab 840 mg: 30 Participants
What this means
The termination of this Phase 1/2a study suggests that the combination of AFM24 and atezolizumab did not meet the criteria for continued development, despite initial findings of low DLTs in Phase 1 and some observed responses in Phase 2a expansion cohorts. While some patients in various advanced solid tumor groups experienced a complete or partial response, the overall profile or efficacy may not have supported further progression of the trial.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05109442, titled "Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers," were posted on 2025-08-20 on clinicaltrials.gov.