A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR-expressing Cancers

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511999-32-00

Acronym

AFM24-102

Enrollment

127

Registered

2024-04-17

Start date

2021-11-19

Completion date

2025-06-11

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced/Metastatic EGFR-expressing Cancers

Brief summary

Dose Escalation Phase (Phase 1): -AEs to be assessed by the incidence and severity of DLT within the DLT observation period (Cycle 1) Phase 2a -ORR according to RECIST v1.1 determined by Investigator assessment

Detailed description

1. Dose Escalation Phase (Phase 1): - Incidence of patients with TEAEs and SAEs - ORR using RECIST v1.1 determined by Investigator assessment - PK parameters of AFM24: Cmax, Tmax, Cmin and AUCtau - Frequency of patients developing ADAs against AFM24, 2.1 Phase 2a: - PFS according to RECIST v1.1 by Investigator assessment - DOR according to RECIST v1.1 by Investigator assessment - CBR according to RECIST v1.1 by Investigator assessment, 2.2 Phase 2a: - DCR according to RECIST v1.1 by Investigator assessment - Incidence of patients with TEAEs and SAEs - PK parameters of AFM24: Cmax, Tmax, Cmin, and AUCtau - Frequency of patients developing ADAs against AFM24

Interventions

DRUGRAMUCIRUMAB

DRUGAFM24

DRUGATEZOLIZUMAB

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation Phase (Phase 1): -AEs to be assessed by the incidence and severity of DLT within the DLT observation period (Cycle 1) Phase 2a -ORR according to RECIST v1.1 determined by Investigator assessment	—

Secondary

Measure	Time frame
1. Dose Escalation Phase (Phase 1): - Incidence of patients with TEAEs and SAEs - ORR using RECIST v1.1 determined by Investigator assessment - PK parameters of AFM24: Cmax, Tmax, Cmin and AUCtau - Frequency of patients developing ADAs against AFM24, 2.1 Phase 2a: - PFS according to RECIST v1.1 by Investigator assessment - DOR according to RECIST v1.1 by Investigator assessment - CBR according to RECIST v1.1 by Investigator assessment, 2.2 Phase 2a: - DCR according to RECIST v1.1 by Investigator assessment - Incidence of patients with TEAEs and SAEs - PK parameters of AFM24: Cmax, Tmax, Cmin, and AUCtau - Frequency of patients developing ADAs against AFM24	—

Measure

Time frame

—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026