A Phase 1 interventional study of FATE-NK100 and Cetuximab in HER2 Positive Gastric Cancer, Colorectal Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Fate Therapeutics. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Fate Therapeutics · Phase 1, Interventional, and Treatment
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Among 2,338 studies in Colorectal Neoplasms with a site in United States — 420 open to participants now, 629 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 1,171st largest by enrollment of the 1,931 interventional ones that give a count, is one of 96 that started in 2018, is one of 551 in phase 1, and was the 1,212th registered.
6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.
Browse Colorectal Neoplasms studies →420 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
Exelixis · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
University of Pennsylvania · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,338 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 817 · Phase 2 790 · Phase 3 132 · Phase 4 19
First in 1981; this study’s year is marked. 96 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is below the median of 76 across 4,801 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
885 of 2,338 have an industry lead sponsor. The 10 most frequent:
Fate Therapeutics is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Fate Therapeutics has 5 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
227 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Add all 227 to your calendar (.ics) → With an account.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Have central nervous system disease (CNS) as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
Drug: FATE-NK100
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.
Drug: FATE-NK100 · Drug: Trastuzumab
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.
Drug: FATE-NK100 · Drug: Cetuximab
FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
Epidermal growth factor receptor inhibitor antineoplastic agent
Also known as: Erbitux
HER2/neu receptor inhibitor
Also known as: Herceptin
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).
Time frame: 28 days
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.
Time frame: 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.
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
Plan to share: No
Ran from Jan 2018 to primary completion in May 2020, 28 months.
Of 268 industry-sponsored phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's 28 months is below that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allogeneic CD3- CD19- CD57+ NKG2C+ NK Cells FATE-NK100