FT836 alone or with chemotherapy and antibody drugs for advanced solid tumors.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, dose-finding trial that gives FT836 either by itself or combined with paclitaxel and/or monoclonal antibodies (trastuzumab or cetuximab) to people with advanced solid tumors. The study enrolls participants with cancers such as non-small cell lung, colorectal, breast, ovarian, or endometrial carcinoma that have progressed after prior systemic therapy. Researchers will escalate doses to determine safety, tolerability, and a recommended phase 2 dose for the combinations, monitoring labs, adverse events, and clinical response. Each combination will be evaluated with and without paclitaxel to understand how adding chemotherapy affects safety and dosing.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• University of Minnesota Masonic Cancer Center
  Minneapolis, Minnesota, United States Recruiting
• Thomas Jefferson University, Sidney Kimmel Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• M. D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Fate Trial Disclosure
• Email: FateTrialDisclosure@fatetherapeutics.com
• Phone: 858-875-1800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.