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Study of TBX-3400 in Subjects With Solid Malignant Tumors Resistant or Refractory to Standard Therapies

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ClinicalTrials.gov Identifier: NCT04640246
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Taiga Biotechnologies, Inc.

Tracking Information
First Submitted Date  ICMJE November 17, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date January 5, 2021
Estimated Study Start Date  ICMJE January 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
The primary endpoint is the incidence and severity of treatment-emergent adverse events (TEAEs), including the incidence of dose-limiting toxicities (DLTs), graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. [ Time Frame: 8 months ]
Adverse events from subject reporting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
  • Tumor Responses as defined by RECIST [ Time Frame: 8 months ]
    Tumor measurements to assess disease state
  • Assessment of concentrations of certain proteins such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400 [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Presence and/or concentration of anti TBX-3400 antibodies [ Time Frame: 8 months ]
    Measure of immunogenicity of TBX-3400
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2020)
  • Quantification of the concentration of interleukin-1 (IL-1) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interleukin-6 (IL-6) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon-alpha (IFN-α) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon-gamma inducible protein 10kD (IP-10) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon-gamma (IFN-γ) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of transforming growth factor-beta (TGF-ß) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of TBX-3400 in Subjects With Solid Malignant Tumors Resistant or Refractory to Standard Therapies
Official Title  ICMJE A Phase 1 Single-Center Dose-Escalation Study of the Safety, Tolerability and Early Efficacy of TBX-3400 in Subjects With Solid Malignant Tumors Resistant or Refractory to Standard Therapies
Brief Summary

This is a study of treatment with TBX-3400 in subjects with solid malignant tumors that are resistant or refractory to standard therapies.

The subject's own blood cells are exposed to a protein that has been shown in the laboratory to result in anti-tumor activity.

The study hypothesis is that TBX-3400 cells will enhance anti-tumor activity and improve the body's immune response to the tumor.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Tumor, Solid
  • Refractory Cancer
Intervention  ICMJE Biological: TBX-3400
Autologous transfusion
Study Arms  ICMJE Experimental: TBX-3400
TBX-3400 by intravenous infusion
Intervention: Biological: TBX-3400
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 17, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in the study:

  1. Histologically or cytologically confirmed diagnosis of malignant solid tumor/s
  2. Male or female subjects age 18 or older
  3. Metastatic tumor that has failed at least one line of therapy with further options being non-curative; or with metastatic tumor and patient refuses conventional treatment, at the discretion of the investigator
  4. At least 30 days since the last dose of medication to treat their malignancy, or, at investigator discretion, at least 7 days since last dose of treatment with medication with a short half-life.
  5. Measurable or evaluable disease by RECIST version 1.1
  6. Capable of understanding and complying with protocol requirements
  7. A life expectancy of greater than 12 weeks at Screening
  8. ECOG Performance Status of 0 to 2
  9. Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures
  10. Adequate bone marrow, liver, and renal function at screening as defined below:

    • hemoglobin ≥8.0 g/dL (transfusions allowed)
    • total lymphocyte count ≥500/µL
    • absolute neutrophil count ≥1500/µL
    • platelet count ≥100,000/µL (transfusions allowed)
    • alanine transaminase and aspartate transaminase ≤3.0 times the upper limit of normal (ULN), or ≤5 times ULN for subjects with known hepatic metastases
    • total serum bilirubin ≤1.5 x the ULN; ≤2.0 x the ULN if liver metastases are present; subjects with a known history of Gilbert's syndrome (≤3.0 x the ULN) and/or isolated elevations of indirect bilirubin are eligible for study participation
    • estimated glomerular filtration rate ≥50 mL/min/1.73 m2 (using Cockcroft Gault formula)

Exclusion Criteria:

Subjects who meet any of the following criteria will not be eligible for participation in the study:

  1. Pregnant or breast feeding
  2. Require systemic pharmacologic doses of corticosteroids at or above the equivalent of 10 mg/day of prednisone; replacement doses, topical, ophthalmologic and inhalational steroids are permitted
  3. Active, symptomatic central nervous system (CNS) metastases. Subjects with CNS metastases are eligible for the trial if the metastases have been treated by surgery and/or radiotherapy and the patient is off corticosteroids and is neurologically stable for at least 7 days prior to screening
  4. Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the investigator would make the patient unable to cooperate or participate in the trial
  5. Severe uncontrolled cardiac disease within 3 months of study entry, including unstable or new onset angina, myocardial infarction or cerebrovascular accident
  6. Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception
  7. Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  8. Symptomatic congestive heart failure, defined as New York Heart Association Class II or higher
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yosef Refaeli +1-720-859-3547 refaeli@taigabiotech.com
Contact: Vivienne Margolis +972-52-4639634 vmargolis@taigabiotech.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640246
Other Study ID Numbers  ICMJE TBX-3400-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taiga Biotechnologies, Inc.
Study Sponsor  ICMJE Taiga Biotechnologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taiga Biotechnologies, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP