No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
119 (estimated)
Sponsor
Fate Therapeutics · Industry
Who this trial is looking for
This trial is looking for people with advanced solid tumors who have not responded to previous treatments. Participants will receive FT836 alone or with other treatments and will be closely monitored for safety and side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have advanced cancer that cannot be cured and has progressed after at least one previous treatment.
I have good organ function as shown by my lab results.
I have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
I have measurable cancer that can be evaluated.
I am willing to have biopsies during the study.
I have been assessed for disease within 28 days before starting.
I have enough healthy organs to qualify for the study.
You may not be able to join if
I have significant heart problems or recent heart attack.
I have received other cancer treatments within 2 weeks before starting.
I have active cancer in my brain.
I have had certain brain conditions or medications in the past 6 months.
I need immunosuppressive therapy.
I have a history of severe side effects from cancer immunotherapy.
I have significant nerve damage that affects my daily activities.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a Phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without chemotherapy and/or trastuzumab or cetuximab
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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) \>100…
Inclusion Criteria:
* 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 Criteria:
* 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 first 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.
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