FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
NCT ID: NCT07216105
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
113 participants
INTERVENTIONAL
2025-11-04
2030-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regimen A ( FT836)
Participants receive FT836 monotherapy
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Regimen B ( Paclitaxel + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Paclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
Regimen C ( Cetuximab + FT836)
Participants receive FT836 combined with cetuximab
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Cetuximab
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Regimen D ( Paclitaxel + Cetuximab + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836 combined with cetuximab
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Paclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
Cetuximab
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Regimen E ( Trastuzumab + FT836))
Participants receive FT836 combined with trastuzumab
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Trastuzumab
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Regimen F ( Paclitaxel + Trastuzumab + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836 combined with trastuzumab
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Paclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
Trastuzumab
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FT836
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
Paclitaxel
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
Cetuximab
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
Trastuzumab
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Evidence of adequate organ function as determined by all of the following:
* Absolute neutrophil count (ANC) \>1000/µL without growth factor support within 7 days prior to start of first study intervention
* Platelet count ≥75,000/µL without transfusion support within 14 days prior to start of first study intervention
* Estimated creatinine clearance ≥50 mL/minute by Cockcroft-Gault method or other standard institutional method
* Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN
* Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN
* Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases, ALP ≤5 × ULN
* Oxygen saturation \>90% on room air
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
* Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention.
* Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.
Exclusion Criteria
* Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of fifirst study intervention, whichever is shorter.
* Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.
* Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol.
* Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase.
* Grade ≥2 peripheral neuropathy limiting instrumental activities of daily living.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fate Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian Dempster
Role: STUDY_DIRECTOR
Fate Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Principle Investigator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FT836-101
Identifier Type: -
Identifier Source: org_study_id