NCT05099549

Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: NKGen Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.

Detailed description

The study will be conducted in two phases. The Phase 1/dose escalation phase will gather preliminary safety and tolerability data for escalating doses of AFM24 in combination with SNK01 at a fixed dose in order to determine the MTD/RP2D for the combination dose regimen to be used in the Phase 2a/expansion. The Phase 2a/expansion portion of the study will gather additional safety, tolerability, efficacy, and anti-tumor activity information for the combination of AFM24 with SNK01 in subjects with three types of advanced or metastatic EGFR-expressing cancers.

Conditions

• Squamous Cell Carcinoma of Head and Neck
• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Advanced Solid Tumor
• Refractory Tumor
• Metastatic Tumor

Interventions

Type	Name	Description
DRUG	AFM24	Tetravalent, bispecific EGFR- and CD16A-binding innate cell engager.
BIOLOGICAL	SNK01	Patient-specific ex-vivo expanded autologous natural killer cells.

Timeline

• Start date: 2021-11-03
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2021-10-29
• Last updated: 2024-03-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study