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Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors

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ClinicalTrials.gov Identifier: NCT03385486
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Taiga Biotechnologies, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE June 2, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
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 4.03 [ Time Frame: 26 months ]
Adverse events from subject reporting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Tumor responses as defined by RECIST version 1.1 [ Time Frame: 26 months ]
    Tumor measurements to assess disease state
  • Tumor responses as defined by irRECIST [ Time Frame: 26 months ]
    Tumor measurements to assess disease state
  • Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400 [ Time Frame: 26 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Presence and/or concentration of anti TBX-3400 antibodies [ Time Frame: 26 months ]
    Measure of immunogenicity of TBX-3400
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 20, 2017)
  • Quantification of the concentration of interleukin-1 (IL-1) in plasma [ Time Frame: 26 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interleukin-6 (IL-6) in plasma [ Time Frame: 26 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon-alpha (INF-α) in plasma [ Time Frame: 26 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon gamma inducible protein 10 kD (IP-10) in plasma [ Time Frame: 26 months ]
    Preliminary efficacy assessment to measure activity of TBX-3400
  • Quantification of the concentration of interferon-gamma (IFN-γ) in plasma [ Time Frame: 26 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: 26 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 Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
Official Title  ICMJE A Phase 1 Multi-Center Dose-Escalation Study of the Safety, Tolerability and Early Efficacy of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
Brief Summary

This is a study of transfusion of TBX-3400 in patients with stage III and IV melanoma resistant or refractory to Immune Checkpoint Inhibitors.

The patient'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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:

The study will consist of a Dose Escalation Phase and a Dose Expansion Phase. TBX-3400 will be administered on Day 1 of each treatment cycle and can be repeated.

In the Dose Escalation Phase, a "3+3" design will be employed. Each dose cohort will initially enroll 3 patients. Enrollment and treatment of the first 3 patients in the first cohort will be staggered to allow for evaluation of safety. After each cohort has been enrolled and all patients in the cohort have completed Cycle 1, a Data Safety Monitoring Committee will review cumulative safety data to determine whether to proceed with further dose escalation.

Each cohort may be expanded in groups of 3 patients to a maximum of 12 patients. Up to six TBX 3400 dose levels will be evaluated during the Dose Escalation Phase of the study.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage III Melanoma
  • Stage IV Melanoma
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: December 20, 2017)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  1. Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma
  2. Male or female patients age 18 or older
  3. Previously treated with checkpoint inhibitor therapy either alone or in combination with either stable disease or progressive disease per RECIST version 1.1 (there is no minimum treatment duration for patients who have progressive disease while on checkpoint inhibitor therapy)
  4. Measurable or evaluable disease by RECIST version 1.1
  5. Capable of understanding and complying with protocol requirements
  6. A life expectancy of greater than 24 weeks at Screening
  7. ECOG Performance Status of 0 to 2
  8. Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures
  9. Adequate bone marrow, liver, and renal function as defined below:

    • hemoglobin ≥8.0 g/dL (transfusions allowed)
    • 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 patients with known hepatic metastases
    • total serum bilirubin ≤1.5 x the ULN; ≤2.0 x the ULN if liver metastases are present; patients 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 m^2 (using Cockcroft Gault formula)

Exclusion Criteria:

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

  1. Pregnant or breast feeding
  2. Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to Grade 1 or better
  3. 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
  4. Active, symptomatic central nervous system (CNS) metastases. Patients 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
  5. 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
  6. Severe uncontrolled cardiac disease within 3 months of study entry, including unstable or new onset angina, myocardial infarction or cerebrovascular accident
  7. Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception
  8. Known infection with human immunodeficiency virus (HIV) that is not well controlled on anti-retroviral therapy as defined by HIV RNA more than 400 copies/mL or severely symptomatic
  9. Presence of Hepatitis B and/or Hepatitis C active infection
  10. 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, PhD +1-720-859-3547 refaeli@taigabiotech.com
Contact: Vivienne Margolis +972-52-463-9634 vmargolis@taigabiotech.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03385486
Other Study ID Numbers  ICMJE TBX-3400-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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