Refractory CancerPhase 1NCT03941262
Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy
A Phase 1 study testing SNK01, Avelumab and Pembrolizumab in people with Refractory Cancer and Metastatic Cancer, run by NKGen Biotech, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Cancer, Metastatic Cancer, Recurrent Cancer
- What is being tested?
- SNK01, Avelumab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 17 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Research Center
Santa Monica, California, 90403
About this study
Official title: 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
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
- Refractory Cancer, Metastatic Cancer, Recurrent Cancer, Unresectable Carcinoma, Solid Tumor, Adult, Advanced Cancer
- Being tested
- SNK01, Avelumab, Pembrolizumab
- 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
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNK01Biological
Patient-specific ex vivo expanded autologous natural killer cells
AvelumabDrug
Also called Bavencio
Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).
PembrolizumabDrug
Also called Keytruda
Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Low dose SNK01 | Experimental | SNK01 (low dose) administered once a week for five weeks. Receives: Biological: SNK01 |
| Cohort 2 - Medium dose SNK01 | Experimental | SNK01 (medium dose) administered once a week for five weeks. Receives: Biological: SNK01 |
| Cohort 3 - High dose SNK01 | Experimental | SNK01 (high dose) administered once a week for five weeks. Receives: Biological: SNK01 |
| Cohort 4 - SNK01 with avelumab | Experimental | SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles. Receives: Biological: SNK01; Drug: Avelumab |
| Cohort 4 - SNK01 with pembrolizumab | Experimental | SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles. Receives: Biological: SNK01; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start15 Jul 2019
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NKGen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Chang, MPH, Study director, NKGen Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941262
- Sponsor's protocol ID
- SNK01-US01
- Status last verified
- Jul 2023
- First submitted
- 3 May 2019
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03941262
- Acronym / sponsor ID
- SNK01-US01
- Conditions
- Refractory Cancer, Metastatic Cancer, Recurrent Cancer, Unresectable Carcinoma, Solid Tumor, Adult, Advanced Cancer
- Keywords
- Natural killer cell, NK cell, Expanded natural killer cell, Immunotherapy, Cancer, Metastatic cancer, Advanced solid tumor, Refractory cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NKGen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Low dose SNK01 | Experimental | Biological: SNK01SNK01 (low dose) administered once a week for five weeks. |
| Cohort 2 - Medium dose SNK01 | Experimental | Biological: SNK01SNK01 (medium dose) administered once a week for five weeks. |
| Cohort 3 - High dose SNK01 | Experimental | Biological: SNK01SNK01 (high dose) administered once a week for five weeks. |
| Cohort 4 - SNK01 with avelumab | Experimental | Biological: SNK01, Drug: AvelumabSNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles. |
| Cohort 4 - SNK01 with pembrolizumab | Experimental | Biological: SNK01, Drug: PembrolizumabSNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNK01Patient-specific ex vivo expanded autologous natural killer cells | Biological | Cohort 1 - Low dose SNK01, Cohort 2 - Medium dose SNK01, Cohort 3 - High dose SNK01, Cohort 4 - SNK01 with avelumab, Cohort 4 - SNK01 with pembrolizumab |
| AvelumabAlso: BavencioAvelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1). | Drug | Cohort 4 - SNK01 with avelumab |
| PembrolizumabAlso: KeytrudaPembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1). | Drug | Cohort 4 - SNK01 with pembrolizumab |
Primary outcome
To assess the safety profile
Time frame: Up to 6 months
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.
3 secondary outcomes
To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer
Time frame: Up to 12 months
To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer
Time frame: Up to 12 months
To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Chang, MPH study director
NKGen Biotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNK01, Avelumab and Pembrolizumab in people with Refractory Cancer and Metastatic Cancer, run by NKGen Biotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety profile (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.