Stage III MelanomaPhase 1NCT03385486
Study of TBX-3400 in Patients With Stage III and IV Melanoma Resistant or Refractory to Immune Checkpoint Inhibitors
A Phase 1 study testing TBX-3400 in people with Stage III Melanoma and Stage IV Melanoma, run by Taiga Biotechnologies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Melanoma, Stage IV Melanoma
- What is being tested?
- TBX-3400
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2019to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for participation in the study:
- Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma
- Male or female patients age 18 or older
- 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)
- Measurable or evaluable disease by RECIST version 1.1
- Capable of understanding and complying with protocol requirements
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- A life expectancy of greater than 24 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 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)
Who cannot join
- Patients who meet any of the following criteria will not be eligible for participation in the study:
- Pregnant or breast feeding
- Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to Grade 1 or better
- 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
- 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
- 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
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- Severe uncontrolled cardiac disease within 3 months of study entry, including unstable or new onset angina, myocardial infarction or cerebrovascular accident
- Women of childbearing potential who are unable or unwilling to use an acceptable method of contraception
- 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
- Presence of Hepatitis B and/or Hepatitis C active infection
- Symptomatic congestive heart failure, defined as New York Heart Association Class II or higher
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Cancer Center
Denver, Colorado, 80045
Theresa Medina, MD, 720-848-7135, Theresa.Medina@ucdenver.edu
- Recruiting
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Dr. Inderjit Mehmi, MD, 310-294-0438, imehmi@theangelesclinic.org
About this study
Official title: 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
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.
- Conditions
- Stage III Melanoma, Stage IV Melanoma
- Being tested
- TBX-3400
- Keywords
- Melanoma, Resistant, Refractory
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBX-3400Biological
Autologous transfusion
| Study group | Role | What they receive |
|---|---|---|
| TBX-3400 | Experimental | TBX-3400 by intravenous infusion Receives: Biological: TBX-3400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Adverse events from subject reporting
Measured: 26 months
Secondary outcomes (4)
Tumor responses as defined by RECIST version 1.1
Tumor measurements to assess disease state
Measured: 26 months
Tumor responses as defined by irRECIST
Tumor measurements to assess disease state
Measured: 26 months
Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400
Preliminary efficacy assessment to measure activity of TBX-3400
Measured: 26 months
Presence and/or concentration of anti TBX-3400 antibodies
Measure of immunogenicity of TBX-3400
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start2 Jun 2019
- Primary completionFeb 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiga Biotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385486
- Sponsor's protocol ID
- TBX-3400-001
- Status last verified
- May 2022
- First submitted
- 3 Dec 2017
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03385486
- Acronym / sponsor ID
- TBX-3400-001
- Conditions
- Stage III Melanoma, Stage IV Melanoma
- Keywords
- Melanoma, Resistant, Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Taiga Biotechnologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| TBX-3400 | Experimental | Biological: TBX-3400TBX-3400 by intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must meet all of the following inclusion criteria to be eligible for participation in the study:
- Histopathologically confirmed diagnosis of advanced, unresectable or metastatic malignant melanoma
- Male or female patients age 18 or older
- 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)
- Measurable or evaluable disease by RECIST version 1.1
Key exclusion criteria (11 listed)
- Patients who meet any of the following criteria will not be eligible for participation in the study:
- Pregnant or breast feeding
- Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to Grade 1 or better
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBX-3400Autologous transfusion | Biological | TBX-3400 |
Primary outcome
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
4 secondary outcomes
Tumor responses as defined by RECIST version 1.1
Time frame: 26 months
Tumor responses as defined by irRECIST
Time frame: 26 months
Assessment of concentrations of certain chemokines, such as cluster of differentiation 69 (CD69), as biomarkers of activity of TBX-3400
Time frame: 26 months
Presence and/or concentration of anti TBX-3400 antibodies
Time frame: 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBX-3400 in people with Stage III Melanoma and Stage IV Melanoma, run by Taiga Biotechnologies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosef Refaeli, PhD (+1-720-859-3547, refaeli@taigabiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.