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.

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 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.

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