Actively Recruiting
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Led by Fate Therapeutics · Updated on 2026-04-07
113
Participants Needed
5
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.
CONDITIONS
Official Title
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Disease that is not curable and has relapsed or progressed after at least one prior systemic therapy
- Adequate organ function including neutrophil count >1000/µL without growth factors within 7 days before starting treatment
- Platelet count ≥75,000/µL without transfusion within 14 days before treatment
- Creatinine clearance ≥50 mL/min
- Total bilirubin ≤1.5 times upper limit of normal, or ≤3 times with Gilbert syndrome
- AST or ALT ≤3 times upper limit of normal, or ≤5 times with liver metastases
- Alkaline phosphatase ≤2.5 times upper limit of normal, or ≤5 times with liver or bone metastases
- Oxygen saturation >90% on room air
- Performance status of 0 or 1 on ECOG scale
- Presence of measurable disease by RECIST v1.1 within 28 days before treatment
- Willingness to undergo biopsies of accessible lesions during treatment
You will not qualify if you...
- Significant cardiovascular disease including unstable arrhythmias, recent heart attack within 6 months, unstable angina, heart failure of NYHA Grade 2 or higher, or ejection fraction <50%
- Receipt of biological therapy, chemotherapy, investigational therapy, or radiation within 2 weeks or five half-lives before treatment
- Active central nervous system involvement by cancer, or recent CNS disease without stable findings for at least 4 weeks
- Non-malignant CNS diseases such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease within 6 months
- Current or expected need for systemic immunosuppressive therapy >5 mg prednisone daily from start of treatment to Day 29, except corticosteroids for chemotherapy side effects
- History of severe immune-related adverse events or significant eye toxicity from prior cancer immunotherapy
- Peripheral neuropathy Grade 2 or higher that limits daily activities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Southern California
La Jolla, California, United States, 90033
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fate Trial Disclosure
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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