FT836 for Advanced Solid Tumors
This study is testing a new drug called FT836, alone or with other common cancer treatments like paclitaxel, cetuximab, or trastuzumab. It's for people with advanced solid tumors such as non-small cell lung cancer, colorectal cancer, breast cancer, ovarian cancer, or endometrial carcinoma, whose cancer has progressed after previous treatments. The main goals are to see how safe FT836 is, what side effects it might cause, and to find the best dose to use in future studies. The study plans to enroll 113 participants. The current status of the study is unclear.
- Study design
- This is a Phase 1 study, meaning it's an early-stage trial focused on safety. It plans to enroll 113 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety are measured from Day 1 through Day 29 of Cycle 1, with each cycle lasting 56 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07216105
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentFate Therapeutics
~113 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:FT836PaclitaxelCetuximabTrastuzumab
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with dose limiting toxicities (DLTs)
Measured over From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
+1 more outcome measured
Conditions
Where it's being run
5 sites across 4 statesCalifornia2
Minnesota1
Pennsylvania1
Texas1
Study leadership
- Brian Dempster · STUDY_DIRECTOR · Fate Therapeutics
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy.
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
Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction \<50%.
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.
What this trial measures
- Number of participants with dose limiting toxicities (DLTs)From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
The number of participants experiencing ≥1 DLT will be reported.
- Severity of DLTsFrom Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).