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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.

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.


Condition or disease Intervention/treatment Phase
Cancer Tumor, Solid Refractory Cancer Biological: TBX-3400 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: TBX-3400
TBX-3400 by intravenous infusion
Biological: TBX-3400
Autologous transfusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Tumor Responses as defined by RECIST [ Time Frame: 8 months ]
    Tumor measurements to assess disease state

  2. 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

  3. Presence and/or concentration of anti TBX-3400 antibodies [ Time Frame: 8 months ]
    Measure of immunogenicity of TBX-3400


Other Outcome Measures:
  1. Quantification of the concentration of interleukin-1 (IL-1) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400

  2. Quantification of the concentration of interleukin-6 (IL-6) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400

  3. Quantification of the concentration of interferon-alpha (IFN-α) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400

  4. 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

  5. Quantification of the concentration of interferon-gamma (IFN-γ) in plasma [ Time Frame: 8 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640246


Contacts
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Contact: Yosef Refaeli +1-720-859-3547 refaeli@taigabiotech.com
Contact: Vivienne Margolis +972-52-4639634 vmargolis@taigabiotech.com

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Principal Investigator: Salomon Stemmer, MD         
Sponsors and Collaborators
Taiga Biotechnologies, Inc.
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Responsible Party: Taiga Biotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT04640246    
Other Study ID Numbers: TBX-3400-003
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Taiga Biotechnologies, Inc.:
Cancer
Solid tumor
Malignant
Refractory
Resistant
Additional relevant MeSH terms:
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Neoplasms