HER2 Positive Gastric CancerPhase 1NCT03319459
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
A Phase 1 study testing FATE-NK100, Cetuximab and Trastuzumab in people with HER2 Positive Gastric Cancer and Colorectal Cancer, run by Fate Therapeutics at 4 sites in United States.
Trial summary
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- FATE-NK100, Cetuximab and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jan 2018to 15 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
- Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
- Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
- Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
- Presence of measurable disease by RECIST 1.1
- Life expectancy of at least 3 months.
- Provision of signed and dated informed consent form (ICF).
- Stated willingness to comply with study procedures and duration.
Who cannot join
- Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- Evidence of insufficient organ function as determined by the protocol.
- Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
- Have central nervous system disease (CNS) as follows:
- Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
Show all 12Show fewer
- MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
- Myocardial infarction (MI) within 6 months of Screening Visit.
- Severe asthma.
- Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
- Uncontrolled infections.
- Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
Baylor Scott & White Research Institute
Dallas, Texas, 75246
University of Minnesota
Minneapolis, Minnesota, 55455
UCSD Moores Cancer Center
San Diego, California, 92037
About this study
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:
- Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
- Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
- Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
- Conditions
- HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, EGFR Positive Solid Tumor, Advanced Solid Tumors, HER2-positive Breast Cancer
- Being tested
- FATE-NK100, Cetuximab, Trastuzumab
- Keywords
- Solid Tumor, HER2, EGFR, Advanced Solid Tumor, Breast Cancer, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Gastric Cancer, HER2 Positive, EGFR Positive, EGFR+, HER2+, Immunotherapy, NK cell therapy, Natural killer cell therapy, antibody-dependent cell-mediated cytotoxicity, ADCC, Non small cell lung cancer, Renal cancer
- Medical subject headings
- Colorectal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Pancreatic Neoplasms, Melanoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FATE-NK100Drug
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
CetuximabDrug
Also called Erbitux
Epidermal growth factor receptor inhibitor antineoplastic agent
TrastuzumabDrug
Also called Herceptin
HER2/neu receptor inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. Receives: Drug: FATE-NK100 |
| Regimen B | Experimental | FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. Receives: Drug: FATE-NK100; Drug: Trastuzumab |
| Regimen C | Experimental | Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors. Receives: Drug: FATE-NK100; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).
Measured: 28 days
Secondary outcomes (2)
Objective-response rate (ORR)
Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.
Measured: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
Pharmacokinetics (PK) of FATE-NK100
The PK of FATE-NK100, as assessed by the proportion of lymphocytes in peripheral blood that are of donor/product origin at the specified time points.
Measured: 0 days, 1 day, 3 days, 5 days, 8 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Jan 2018
- Primary completion29 May 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Gastric 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Chou, MD, Study director, Fate Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319459
- Sponsor's protocol ID
- NK-101
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2017
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cichocki F, Valamehr B, Bjordahl R, Zhang B, Rezner B, Rogers P, Gaidarova S, Moreno S, Tuininga K, Dougherty P, McCullar V, Howard P, Sarhan D, Taras E, Schlums H, Abbot S, Shoemaker D, Bryceson YT, Blazar BR, Wolchko S, Cooley S, Miller JS. GSK3 Inhibition Drives Maturation of NK Cells and Enhances Their Antitumor Activity. Cancer Res. 2017 Oct 15;77(20):5664-5675. doi: 10.1158/0008-5472.CAN-17-0799. Epub 2017 Aug 8.
PubMed 28790065
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03319459
- Acronym / sponsor ID
- NK-101
- Conditions
- HER2 Positive Gastric Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, EGFR Positive Solid Tumor, Advanced Solid Tumors, HER2-positive Breast Cancer
- Keywords
- Solid Tumor, HER2, EGFR, Advanced Solid Tumor, Breast Cancer, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 24 Oct 2017 (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.
This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:
- Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
- Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
- Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: FATE-NK100FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. |
| Regimen B | Experimental | Drug: FATE-NK100, Drug: TrastuzumabFATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. |
| Regimen C | Experimental | Drug: FATE-NK100, Drug: CetuximabRegimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
- Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
- Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
- Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
- Presence of measurable disease by RECIST 1.1
Key exclusion criteria (12 listed)
- Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- Evidence of insufficient organ function as determined by the protocol.
- Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
- Have central nervous system disease (CNS) as follows:
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 |
|---|---|---|
| FATE-NK100FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity | Drug | Regimen A, Regimen B, Regimen C |
| CetuximabAlso: ErbituxEpidermal growth factor receptor inhibitor antineoplastic agent | Drug | Regimen C |
| TrastuzumabAlso: HerceptinHER2/neu receptor inhibitor | Drug | Regimen B |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: 28 days
The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).
2 secondary outcomes
Objective-response rate (ORR)
Time frame: 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days.
Pharmacokinetics (PK) of FATE-NK100
Time frame: 0 days, 1 day, 3 days, 5 days, 8 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days
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 22 Nov 2021.
- Background: PubMed 28790065Cichocki F, Valamehr B, Bjordahl R, Zhang B, Rezner B, Rogers P, Gaidarova S, Moreno S, Tuininga K, Dougherty P, McCullar V, Howard P, Sarhan D, Taras E, Schlums H, Abbot S, Shoemaker D, Bryceson YT, Blazar BR, Wolchko S, Cooley S, Miller JS. GSK3 Inhibition Drives Maturation of NK Cells and Enhances Their Antitumor Activity. Cancer Res. 2017 Oct 15;77(20):5664-5675. doi: 10.1158/0008-5472.CAN-17-0799. Epub 2017 Aug 8.
- GSK 3 inhibition drives maturation of NK cells and enhances their antitumor activityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jeff Chou, MD study director
Fate Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FATE-NK100, Cetuximab and Trastuzumab in people with HER2 Positive Gastric Cancer and Colorectal Cancer, run by Fate Therapeutics at 4 sites 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 8 inclusion and 12 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 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Incidence of dose-limiting toxicity (DLT) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319459, which also lists 1 linked publication.
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 22 Nov 2021.