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Symptoms and General Pathology

Digestive System Diseases

Carcinoma, Non-Small-Cell Lung

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Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Antibodies

Immunoglobulins

It is estimated that approximately 3-6 subjects will be enrolled per cohort in three dose cohorts for a total of 12-18 participants.

SNK01 (fixed dose) will be administered weekly by IV infusion.

SNK01 (fixed dose) will be administered weekly by IV infusion.

Tetravalent, bispecific EGFR- and CD16A-binding innate cell engager.

AFM24

Patient-specific ex-vivo expanded autologous natural killer cells.

SNK01

Paul Chang, MPH

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.

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.

Subjects will be enrolled sequentially in cohorts of 3 to 6 subjects into Phase 1/dose escalation. The dose escalation will follow the standard oncology Phase 1 3 + 3 dose escalation design. A minimum of 3 cohorts will be utilized and dose increases will be determined by the Safety Review Committee.

Once RP2D is determined in Phase 1/dose escalation, the Phase 2a/expansion phase will begin enrolling up to 121 subjects.

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

Determine the maximum tolerated dose (MTD) of AFM24 in combination with SNK01. To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.

Determine the recommended phase 2 dose (RP2D) of AFM24 in combination with SNK01.

To be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period.

Determine objective response rate (ORR) of AFM24 in combination with SNK01. Determine ORR using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1

Assess safety and tolerability of AFM24 in combination with SNK01. Determine frequency and severity of treatment-emergent AEs (TEAEs) per National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI CTCAE v 5.0).

Determine preliminary efficacy of AFM24 in combination with SNK01. Determine ORR using RECIST v1.1 evaluated by local assessment.

Maximum observed plasma concentration (Cmax) of AFM24

Time to maximum plasma concentration (Tmax) of AFM24

Minimum plasma concentration (Cmin) of AFM24

Area under plasma concentration-time curve for dosing interval (AUCtau) of AFM24

Immunogenicity of AFM24 when AFM24 is given in combination with SNK01 Frequency of subjects developing AFM24 anti drug antibodies (ADAs) through completion of the Phase 1/dose escalation portion

Safety and tolerability of AFM24 in combination with SNK01 Frequency of TEAEs graded according to NCI CTCAE v 5.0

To assess progression-free survival (PFS) according to RECIST v1.1 by local assessment Assess the number of subjects with PFS defined as duration of time from start of combination treatment to date of progression.

To assess duration of response (DOR) according to RECIST v1.1 by local assessment.

To assess clinical benefit rate (CBR) according to RECIST v1.1 by local assessment.

Maximum observed plasma concentration (Cmax) of AFM24.

Time to maximum plasma concentration (Tmax) of AFM24.

Minimum plasma concentration (Cmin) of AFM24.

Area under plasma concentration-time curve for dosing interval (AUCtau) of AFM24.

Immunogenicity of AFM24 when AFM24 is given in combination with SNK01 Frequency of subjects developing AFM24 ADAs and frequency of subjects developing neutralizing ADAs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers	NCT05099549	Squamous Cell C... Carcinoma, Non-... Colorectal Neop... Advanced Solid ... Refractory Tumo... Metastatic Tumo...	AFM24 SNK01	18 Years -	NKGen Biotech, Inc.
Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers	NCT05099549	Squamous Cell C... Carcinoma, Non-... Colorectal Neop... Advanced Solid ... Refractory Tumo... Metastatic Tumo...	AFM24 SNK01	18 Years -	NKGen Biotech, Inc.

Spots Global Cancer Trial Database for cd16a

Every month we try and update this database with for cd16a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd16a

Every month we try and update this database with for cd16a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd16a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.