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

NCT04640246 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: TBX-3400-003
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cancer; Tumor, Solid; Refractory Cancer

Keywords

Cancer; Solid tumor; Malignant; Refractory; Resistant

Outcome Measures

Primary Outcomes (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.

  Adverse events from subject reporting

  8 months

Secondary Outcomes (3)

• Tumor Responses as defined by RECIST

  8 months

• Assessment of concentrations of certain proteins such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400

  8 months

• Presence and/or concentration of anti TBX-3400 antibodies

  8 months

Other Outcomes (6)

• Quantification of the concentration of interleukin-1 (IL-1) in plasma

  8 months

• Quantification of the concentration of interleukin-6 (IL-6) in plasma

  8 months

• Quantification of the concentration of interferon-alpha (IFN-α) in plasma

  8 months

Study Arms (1)

TBX-3400

EXPERIMENTAL

TBX-3400 by intravenous infusion

Biological: TBX-3400

Interventions

TBX-3400 BIOLOGICAL

Autologous transfusion

TBX-3400

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of malignant solid tumor/s
• Male or female subjects age 18 or older
• Metastatic tumor that has failed at least one line of therapy with further options being non-curative; or with metastatic tumor and patient declines standard of care therapies and alternatives offered, at the discretion of the investigator
• At least 28 days or 5 half-lives, since the last dose of medication to treat their malignancy.
• Measurable or evaluable disease by RECIST version 1.1
• Capable of understanding and complying with protocol requirements
• A life expectancy of greater than 12 weeks at Screening
• ECOG Performance Status of 0 to 2
• Written informed consent from the patient or the patient's legally acceptable representative prior to the initiation of any study procedures
• 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

You may not qualify if:

• Subjects who meet any of the following criteria will not be eligible for participation in the study:
• Pregnant or breast feeding
• 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
• 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
• Severe uncontrolled cardiac disease within 3 months of study entry, including unstable or new onset angina, myocardial infarction or cerebrovascular accident
• Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception
• Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (in USA: Known infection with human immunodeficiency virus \[HIV\], hepatitis B or hepatitis C that is not controlled and has any related symptoms)
• Symptomatic congestive heart failure, defined as New York Heart Association Class II or higher
• Systemic lupus erythematous (SLE), inflammatory bowel disease, primary Sjogren's syndrome, rheumatoid arthritis, systemic sclerosis, and granulomatosis with polyangiitis; and any other autoimmune condition that, in the opinion of the investigator, may increase the risk of trial participation or trial drug administration, unless reviewed and approved by the medical monitor.
• Any hematopoietic malignancy
• Have more than one primary cancer diagnosis within the last 3 years
• Organ transplant or requiring immune suppression
• Bullous pemphigoid and other autoimmune diseases of the dermal-epidermal junction; these include bullous pemphigoid, bullous SLE, liner IgA disease, epidermolysis bullosa acquisita, and other pemphigoid variants.

Sponsors & Collaborators

• Taiga Biotechnologies, Inc.: lead

Study Sites (2)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yosef Refaeli

CONTACT

+1-720-859-3547; refaeli@taigabiotech.com

Vivienne Margolis

CONTACT

+972-52-4639634; vmargolis@taigabiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: January 25, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)