Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Neoplasm Metastasis

Stomach Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Pancreatic Neoplasms

Sarcoma

Triple Negative Breast Neoplasms

Recurrence

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Connective and Soft Tissue

Stomach Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Head and Neck Neoplasms

Esophageal Diseases

Neoplastic Processes

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Pancreatic Cancer

Soft Tissue Sarcoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Cetuximab

Immunomodulating Agents

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

SNK01 (low dose) administered once every three weeks in combination with trastuzumab (loading dose of 8 mg/kg on Cycle 1, Day 1, followed by a 6 mg/kg on Cycle 2, Day 1 once every three weeks)

SNK01 (high dose) administered once every three weeks in combination with trastuzumab (loading dose of 8 mg/kg on Cycle 1, Day 1, followed by a 6 mg/kg on Cycle 2, Day 1 once every three weeks)

SNK01 (low dose) administered once every week in combination with cetuximab (loading dose of 400 mg/m2 on Cycle 1, Day 1, followed by a 250 mg/m2 on Cycle 2, Day 1 once every week)

SNK01 (high dose) administered once every week in combination with cetuximab (loading dose of 400 mg/m2 on Cycle 1, Day 1, followed by a 250 mg/m2 on Cycle 2, Day 1 once every week)

SNK01 (TBD RP2D) administered once every three weeks in combination with trastuzumab (loading dose of 8 mg/kg on Cycle 1, Day 1, followed by a 6 mg/kg on Cycle 2, Day 1 once every three weeks)

SNK01 (TBD RP2D) administered once every week in combination with cetuximab (loading dose of 400 mg/m2 on Cycle 1, Day 1, followed by a 250 mg/m2 on Cycle 2, Day 1 once every week)

Patient-specific ex vivo expanded autologous natural killer cells

SNK01

HER2 receptor antagonistic, humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody

EGFR antagonist, chimeric immunoglobulin G subclass 1 (IgG1) monoclonal antibody

Paul Y. Song, MD

The purpose of the Phase 1/2a study is to evaluate the safety and tolerability of SNK01 in combination with trastuzumab or cetuximab in order to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the preliminary efficacy for each combination regimen.

Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers

A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety and Anti-Tumor Activity of Ex Vivo Expanded, Autologous Natural Killer Cells (SNK01) in Combination With Trastuzumab or Cetuximab in Subjects With Advanced/Metastatic HER2- or EGFR-Expressing Cancers

Evaluated by the number of DLTs graded using NCI CTCAE v5.0.

Defined by percentage of subjects with a best response of complete response (CR), partial response (PR) or stable disease (SD) by investigator assessment per RECIST 1.1.

Defined by the time of the date of first dose of study drug until confirmed disease progression based on investigator assessment per RECIST 1.1 or death from any cause, whichever comes first.

Defined as time from first dose of study drug to death due to any cause.

Defined as duration of time from initial response (complete response \[CR\] or partial response \[PR\]) to first documentation of disease progression or death from any cause, whichever occurs first.

Defined as proportion of subjects who achieve an overall tumor response (complete response \[CR\] or partial response \[PR\] or stable disease \[SD\]).

The EORTC QLQ-C30 questionnaire consists of 30 questions, 24 of which are grouped into nine multi-item scales (five functioning scales \[physical, role, cognitive, emotional and social\], three symptom scales \[fatigue, pain and nausea/vomiting\] and one global health status scale). The remaining six questions are single-item scales (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact) and are intended to assess symptoms.

All of the scales and single-item measures are scored on a scale from 0 to 100. A better state of the patient is denoted by a higher score for the functioning scales and global health status, while a worsening state of the patient is denoted by higher scores on the symptom and single-item scales.

The EORTC QLQ-LC13 is a supplementary lung-cancer specific questionnaire and is used in conjunction with the EORTC QLQ-C30 questionnaire. It is comprised of 13 questions, 3 of which are grouped into a multi-item scale to assess dyspnea and 10 of which are single-item scales assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.

All of the scales and single-item measures are scored on a scale from 0 to 100. A better state of the patient is denoted by a higher score for the functioning scales and global health status, while a worsening state of the patient is denoted by higher scores on the symptom and single-item scales.

NKGen Biotech, Inc.

Disease Attributes

Pembrolizumab

Avelumab

Immune Checkpoint Inhibitors

SNK01 (low dose) administered once a week for five weeks.

SNK01 (medium dose) administered once a week for five weeks.

SNK01 (high dose) administered once a week for five weeks.

SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.

SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.

Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).

Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).

Paul Chang, MPH

The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients With Pathologically Confirmed Cancer Refractory to Conventional Therapy

Assessed by the incidence and severity of dose limiting toxicity (DLT) and other adverse events graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 5.0, or the cytokine release syndrome revised grading system.

Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.

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.

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
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers	NCT04464967	Advanced Solid ... Metastatic Canc... HER2-positive B... HER2-positive G... HER-2 Protein O... Esophageal Canc... Ovarian Cancer Endometrium Can... Bladder Cancer Pancreatic Canc... Colorectal Canc... Non Small Cell ... EGF-R Positive ... Head and Neck S... Triple Negative... Cervical Cancer Sarcoma	SNK01 Trastuzumab Cetuximab	18 Years - 75 Years	NKGen Biotech, Inc.
Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy	NCT03941262	Refractory Canc... Metastatic Canc... Recurrent Cance... Unresectable Ca... Solid Tumor, Ad... Advanced Cancer Advanced Solid ...	SNK01 Avelumab Pembrolizumab	18 Years - 75 Years	NKGen Biotech, Inc.
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers	NCT04464967	Advanced Solid ... Metastatic Canc... HER2-positive B... HER2-positive G... HER-2 Protein O... Esophageal Canc... Ovarian Cancer Endometrium Can... Bladder Cancer Pancreatic Canc... Colorectal Canc... Non Small Cell ... EGF-R Positive ... Head and Neck S... Triple Negative... Cervical Cancer Sarcoma	SNK01 Trastuzumab Cetuximab	18 Years - 75 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.
Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers	NCT04464967	Advanced Solid ... Metastatic Canc... HER2-positive B... HER2-positive G... HER-2 Protein O... Esophageal Canc... Ovarian Cancer Endometrium Can... Bladder Cancer Pancreatic Canc... Colorectal Canc... Non Small Cell ... EGF-R Positive ... Head and Neck S... Triple Negative... Cervical Cancer Sarcoma	SNK01 Trastuzumab Cetuximab	18 Years - 75 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 snk01

Every month we try and update this database with for snk01 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 snk01

Every month we try and update this database with for snk01 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 snk01 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.