CompletedNCT03941262Updated Nov 13, 2023

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

A Phase 1 interventional study of SNK01 and Avelumab in Refractory Cancer, Metastatic Cancer and Recurrent Cancer, sponsored by NKGen Biotech, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by NKGen Biotech, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2023, 3 years 7 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 27
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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.

Conditions studied

Refractory Cancer
Metastatic Cancer
Recurrent Cancer
Unresectable Carcinoma
Solid Tumor, Adult
Advanced Cancer
Advanced Solid Tumor

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Keywords

Natural killer cell
NK cell
Expanded natural killer cell
Immunotherapy
Cancer
Metastatic cancer
Advanced solid tumor
Refractory cancer
Recurrent cancer
Unresectable carcinoma
Solid tumor
Neoplasms

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

NKGen Biotech, Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Voluntary written informed consent signed by patient, obtained prior to study enrollment.
Males and females ages 18 to 75 years, inclusive.
Pathologically confirmed diagnosis of refractory cancer that has failed three or more prior lines of conventional standard of care therapy.
Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard curative or beneficial treatments are no longer effective.
Eastern Cooperative Oncology Group (ECOG) performance status \<2.
At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational).
At least 2 weeks since prior palliative radiotherapy.
Adequate bone marrow function:
- Neutrophils: 2.0-8.0 K/uL
- Platelet Count: 140-440 K/uL
- Hemoglobin: 10.0-18.0 g/dL
- No ongoing transfusion requirements
Adequate hepatic function:
- Serum total bilirubin \< 1.5 x upper limit of normal (ULN)
- Serum albumin ≥ 3.0 g/dL
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN
- International normalized ratio (INR) ≤ 1.5 x ULN
Adequate renal function with creatinine ≤ 2.0 mg/dL.
Negative pregnancy test for women of childbearing potential and use of effective contraception (hormonal or barrier method of birth control) during study.

Exclusion criteria

Exclusion Criteria:

Pregnant and/or lactating females.
Life expectancy of less than three months.
Currently being treated by "biological therapy" as defined by the National Cancer Institute (example: checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, Bacillus Calmette-Guerin (BCG), chimeric antigen receptor T cell therapy (CAR-T), and natural killer cell therapy).
Patients tested positive for hepatitis B and/or C surface antigen.
High fever or any active or unresolved infection, including human immunodeficiency virus (HIV) positive.
Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation.
Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process.
Subjects who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.
Adult subjects who lack capacity to consent for themselves and for whom consent must be provided by a legally authorized representative.
For SNK01+avelumab arm only: Subjects with prior hypersensitivity to avelumab or its excipients, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
For SNK01+avelumab arm only: Subjects with a significant immune-mediated adverse event due to a prior checkpoint inhibitor immunotherapy that led to permanent discontinuation of the therapy.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 27 participants (actual)

Study arms

Experimental
Cohort 1 - Low dose SNK01
SNK01 (low dose) administered once a week for five weeks.
Biological: SNK01
Experimental
Cohort 2 - Medium dose SNK01
SNK01 (medium dose) administered once a week for five weeks.
Biological: SNK01
Experimental
Cohort 3 - High dose SNK01
SNK01 (high dose) administered once a week for five weeks.
Biological: SNK01
Experimental
Cohort 4 - SNK01 with avelumab
SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.
Biological: SNK01 · Drug: Avelumab
Experimental
Cohort 4 - SNK01 with pembrolizumab
SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.
Biological: SNK01 · Drug: Pembrolizumab

Interventions

BiologicalSNK01
Patient-specific ex vivo expanded autologous natural killer cells
DrugAvelumab
Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).
Also known as: Bavencio
DrugPembrolizumab
Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).
Also known as: Keytruda

What researchers measure

Primary outcomes

To assess the safety profile
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.
Time frame: Up to 6 months

Secondary outcomes

To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer
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.
Time frame: Up to 12 months
To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer
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.
Time frame: Up to 12 months
To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer
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.
Time frame: Up to 12 months

Study locations

1 site

Sarcoma Oncology Research Center
Santa Monica, California 90403, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03941262
Lead sponsor: NKGen Biotech, Inc.
Responsible party: Sponsor
First posted: May 7, 2019
Start date: Jul 15, 2019
Primary completion: Feb 17, 2023
Completion: Feb 17, 2023
Last update: Nov 13, 2023

Study contacts

Paul Chang, MPH

study director · NKGen Biotech, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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