Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D.

The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab.

AFM24

Atezolizumab 840 MG in 14 ML Injection

Affimed GmbH

Anthony El-Khoueiry, MD

Marina Garassino, MD

Eric Christenson, MD

Danielle Wendler

Jin Won Kim

Yu Jung Kim

Hye Ryun Kim

Byoung Yong Shim

Slawomir Mandziuk, MD

Caezary Szczylik, MD

Rodryg Ramlau, MD

Wojciech Rogowski, MD

Iwona Lugowska, MD

Omar Saavedra, MD

Valentina Boni

Mariano Ponz-Sarvise

Andrés Cervantes, MD

Juanita Lopez, MD

Daniela Morales-Espinosa, MD

AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase (phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab) in the dose escalation phase or the expansion phase only if they are deemed eligible following the safety lead-in phase. Seven days before the planned first combination treatment, patients will receive a single dose of AFM24 and will be observed for any adverse events for 1 week.

The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab.

The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24 in combination with atezolizumab has been determined. The expansion phase of the study is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 in combination with atezolizumab.

The tumor types planned to be studied in the AFM24/atezolizumab combination study will be:

* Non-small cell lung cancer (EGFR-WT), with disease progression after chemotherapy and PD1/PD-L1 targeted therapy
* Gastric/GEJ cancer if intolerant to or with disease progression after standard platinum-based chemotherapy
* Pancreatic/hepatocellular/biliary tract cancer with disease progression after standard of care (SOC) therapy or if there is no appropriate SOC available for their condition
* Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation with disease progression on or after received ≥1 prior lines of treatment for advanced disease, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations

Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers

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

The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE) v5.0

Incidence of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Area under the concentration-time curve over the dose interval (AUCtau)

Measurement of ADAs before and during treatment with AFM24 in combination with atezolizumab

Phase 1: Treatment of escalating doses of AFM24.

Phase 2a: Treatment of AFM24 at maximum tolerated dose/recommended phase 2 dose, stratified into cohorts by tumor type.

Michael Emig, MD

AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell engaging recombinant antibody construct being developed to target EGFR-expressing solid tumors and has been designed to specifically utilize the cytotoxic potential of the innate immune system, in particular natural killer cells and macrophages for the specific and efficient elimination of EGFR-positive cancer cells.

There will be two parts to this study: a dose escalation phase (1) and a dose expansion phase (2a).

The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD) and establish the recommended Phase 2a dose (RP2D).

The dose escalation phase will be followed by the dose expansion phase once the MTD/RP2D of AFM24 monotherapy has been determined. The dose expansion phase of the study using the MTD/P2D is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 as a monotherapy. The expansion phase will have 3 arms based on tumor type.

* Renal cell carcinoma(clear cell), failing standard of care (SoC) that includes TKIs and PD1 targeted therapy
* Non-small cell lung cancer (EGFR-mut), failing SoC TKIs
* Colorectal cancer , failing chemotherapy plus EGFR targeted antibodies

Study to Assess AFM24 in Advanced Solid Cancers

A Phase 1/2a Open Label, Multicenter Study to Access the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients With Advanced Solid Tumors

The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Measurement of ADAs before and throughout treatment with AFM24

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Colorectal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Head and Neck Neoplasms

Neoplastic Processes

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.

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
Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers	NCT05109442	Advanced Solid ...	AFM24 Atezolizumab 84...	18 Years -	Affimed GmbH
Study to Assess AFM24 in Advanced Solid Cancers	NCT04259450	Advanced Solid ...	AFM24	18 Years -	Affimed GmbH
Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers	NCT05109442	Advanced Solid ...	AFM24 Atezolizumab 84...	18 Years -	Affimed GmbH
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.
Study to Assess AFM24 in Advanced Solid Cancers	NCT04259450	Advanced Solid ...	AFM24	18 Years -	Affimed GmbH
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 afm24

Every month we try and update this database with for afm24 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 afm24

Every month we try and update this database with for afm24 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 afm24 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.