FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

NCT07216105 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FT836-101
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 3

Brief Summary

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

Non-Small Cell Lung Cancer; Colorectal Cancer; Breast Cancer; Ovarian Cancer; Endometrial Carcinoma; Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC, NSCLC, CRC

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities (DLTs)

  The number of participants experiencing ≥1 DLT will be reported.

  From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)

• Severity of DLTs

  The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).

  From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Progression-Free Survival (PFS)

  Up to approximately 24 months

• Overall Survival (OS)

  Up to approximately 24 months

Study Arms (6)

Regimen A ( FT836)

EXPERIMENTAL

Participants receive FT836 monotherapy

Drug: FT836

Regimen B ( Paclitaxel + FT836)

EXPERIMENTAL

Participants receive Paclitaxel chemotherapy followed by FT836

Drug: FT836; Drug: Paclitaxel

Regimen C ( Cetuximab + FT836)

EXPERIMENTAL

Participants receive FT836 combined with cetuximab

Drug: FT836; Drug: Cetuximab

Regimen D ( Paclitaxel + Cetuximab + FT836)

EXPERIMENTAL

Participants receive Paclitaxel chemotherapy followed by FT836 combined with cetuximab

Drug: FT836; Drug: Paclitaxel; Drug: Cetuximab

Regimen E ( Trastuzumab + FT836))

EXPERIMENTAL

Participants receive FT836 combined with trastuzumab

Drug: FT836; Drug: Trastuzumab

Regimen F ( Paclitaxel + Trastuzumab + FT836)

EXPERIMENTAL

Participants receive Paclitaxel chemotherapy followed by FT836 combined with trastuzumab

Drug: FT836; Drug: Paclitaxel; Drug: Trastuzumab

Interventions

FT836 DRUG

FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.

Also known as: 836

Regimen A ( FT836); Regimen B ( Paclitaxel + FT836); Regimen C ( Cetuximab + FT836); Regimen D ( Paclitaxel + Cetuximab + FT836); Regimen E ( Trastuzumab + FT836)); Regimen F ( Paclitaxel + Trastuzumab + FT836)

Paclitaxel DRUG

IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7

Also known as: Taxol

Regimen B ( Paclitaxel + FT836); Regimen D ( Paclitaxel + Cetuximab + FT836); Regimen F ( Paclitaxel + Trastuzumab + FT836)

Cetuximab DRUG

Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion

Also known as: Erbitux

Regimen C ( Cetuximab + FT836); Regimen D ( Paclitaxel + Cetuximab + FT836)

Trastuzumab DRUG

trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.

Also known as: Herceptin

Regimen E ( Trastuzumab + FT836)); Regimen F ( Paclitaxel + Trastuzumab + FT836)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fate Therapeutics: lead

Study Sites (3)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Paclitaxel; Cetuximab; Trastuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Brian Dempster

  Fate Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Fate Trial Disclosure

CONTACT

858-875-1800; FateTrialDisclosure@fatetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-11

Locations

US (3)