Solid TumorsPhase 1TAB08NCT03006029
Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms
A Phase 1 study testing TAB08 in people with Solid Tumors, run by Theramab LLC at 1 site in Russia.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- TAB08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- 8 Feb 2017to 13 Aug 2019
- 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
- Subjects or their authorized representatives must be able to provide written informed consent.
- Subjects must have histological or cytological evidence of a solid neoplasm for which standard therapy has failed or does not exist or is not available for patient due to any reason.
- Subjects enrolled in the expansion cohort must have at least one measurable evaluable lesion.
- Subjects must have ECOG (Eastern Cooperation Oncology Group) performance status of 0 or 1.
- Subjects must be ≥ 18 years of age.
- Subjects must have adequate organ function, as defined by the following criteria:
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- Absolute neutrophil count (ANC) > 1,500/µL.
- Platelet count > 75,000/µL.
- Hemoglobin (Hb) > 8.0 g/dL.
- Serum creatinine of < 1.5 x upper limit of normal (ULN) or a calculated Glomerular Filtration Rate of >40 mL/min/1.73m2.
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (< 5 x ULN for subjects with known liver metastases).
- At least 2 weeks or at least 5 half-lives must have elapsed since prior treatment with chemotherapy, targeted therapy, radiotherapy, immunotherapy, or investigational anti-cancer therapy prior to study drug administration. The maximum washout period will not exceed 4 weeks. .
- Subjects must have recovered from the effects of any prior surgery, radiotherapy, localized therapy, or systemic therapy to Grade 1 or lower (except alopecia or anemia - Grade 2 permitted).
- Subjects have a life expectancy ≥ 3 months at study entry.
- Women of childbearing potential and men with partners of childbearing potential must agree to abstain from sexual intercourse or use an effective form of contraception.
Who cannot join
- Subjects with an uncontrolled concurrent illness, including, but not limited to the following: ongoing active infection requiring systemic treatment; uncontrolled endocrine disease; diabetes mellitus or chronic obstructive pulmonary disease (COPD) requiring hospitalization within the preceding 6 months.
- Subjects with uncontrolled arterial hypertension, heart failure by New York Heart Association (NYHA) Class 3 or 4, left ventricular ejection fraction (LVEF) < 50% by echocardiography, myocardial infarction, acute coronary syndrome and/or QT prolongations within the preceding 6 months or history of cerebrovascular accidents including episodes of transient ischemic attacks.
- Subjects with altered mental status or psychiatric illness or social circumstances that would limit compliance with the study requirements and/or obscure the results.
- Immunocompromised subjects, e.g., subjects known to be infected with human immunodeficiency virus (HIV) by medical history, and subjects with active hepatitis A, B, or C by medical history.
- Subjects having untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease. (Subjects with treated metastases, who are off corticosteroids and who are neurologically stable for at least 2 months may participate in the trial.)
- A history of major surgery within 28 days prior to the first dose of study drug.
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- Subjects with history of other malignancies within the preceding 5 years (except for subjects with non-melanoma skin cancers, cervical intra-epithelial neoplasia, prostate cancer Gleason ≤ 6 and Prostate Specific Antigen (PSA) < 10 ng/mL, radically excised lobular breast carcinoma in situ or ductal breast carcinoma in situ ≤ 15 mm) unless they have undergone potentially curative therapy and have had no evidence of disease for 3 years (ie, 5 years since diagnosis, no treatment or symptoms of disease for the last 3 years).
- Women who are pregnant or nursing.
- Subjects with any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the opinion of the investigator, contraindicates use of the investigational drug, or may render the subject as excessively high risk for treatment complications.
- Subjects with any other condition as determined by medical history, including substance abuse that, in the opinion of the investigator, would render the subject unable to cooperate in the trial or place the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
Russia1 site
GBU Ryazanskoy Oblasti "Oblastnoy klinicheckiy oncologicheskiy dispanser"
Ryazan
About this study
Official title: A Phase 1b Multiple Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid malignancies.
Read the detailed description
This is an open-label, multi-center, sequential groups, dose escalation study of TAB08 in patients with metastatic or unresectable advanced solid malignancies. The study will consist of 2 parts: a dose-escalation part with a standard "3+3" design, followed by a dose-expansion part once the maximum tolerated dose (MTD) has been determined.
Patients must have documented recurrent or refractory solid tumors; patients enrolled in the dose-expansion part of the trial must have least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent, patients will be screened for entry into the study.
- Conditions
- Solid Tumors
- Being tested
- TAB08
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAB08Drug
Also called Theralizumab
The initial dose of TAB08 will be 1 µg/kg TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| TAB08( Theralizumab) | Experimental | TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle. Receives: Drug: TAB08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of the Dose-limiting toxicity (DLT)
Measured: DLT assessment will be performed within first 2 weeks of treatment
Secondary outcomes (6)
Adverse events (including local reactions) frequency, seriousness and severity
Measured: Through study completion, not less than 8 weeks
TAB08 concentrations in peripheral blood
Measured: First 4 weeks of TAB08 administration
Tumor response to TAB08 according to immune-related Response Criteria in Solid Tumors (irRECIST)
Measured: Through study completion, not less than 12 weeks
Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at designated timepoints comparing to Baseline.
Measured: Through study completion, not less than 8 weeks
Change of T-lymphocytes subsets in percent in peripheral blood at designated timepoints comparing to Baseline.
Measured: Through study completion, not less than 8 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at designated timepoints comparing to Baseline.
Measured: Through study completion, not less than 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start8 Feb 2017
- Primary completion14 May 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theramab LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniil G Nemenov, MD, Study director, Theramab LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006029
- Sponsor's protocol ID
- TAB08-ONC-01
- Acronym
- TAB08
- Status last verified
- Oct 2021
- First submitted
- 29 Nov 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Multiple Dose Escalation Study of TAB08 in Patients With Advanced Solid Neoplasms
- ClinicalTrials.gov ID
- NCT03006029
- Acronym / sponsor ID
- TAB08 / TAB08-ONC-01
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Theramab LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose of TAB08 when administered intravenously (i.v.) to patients with advanced solid malignancies.
Detailed description
This is an open-label, multi-center, sequential groups, dose escalation study of TAB08 in patients with metastatic or unresectable advanced solid malignancies. The study will consist of 2 parts: a dose-escalation part with a standard "3+3" design, followed by a dose-expansion part once the maximum tolerated dose (MTD) has been determined.
Patients must have documented recurrent or refractory solid tumors; patients enrolled in the dose-expansion part of the trial must have least one lesion that may qualify as a target lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent, patients will be screened for entry into the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAB08( Theralizumab) | Experimental | Drug: TAB08TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects or their authorized representatives must be able to provide written informed consent.
- Subjects must have histological or cytological evidence of a solid neoplasm for which standard therapy has failed or does not exist or is not available for patient due to any reason.
- Subjects enrolled in the expansion cohort must have at least one measurable evaluable lesion.
- Subjects must have ECOG (Eastern Cooperation Oncology Group) performance status of 0 or 1.
- Subjects must be ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Subjects with an uncontrolled concurrent illness, including, but not limited to the following: ongoing active infection requiring systemic treatment; uncontrolled endocrine disease; diabetes mellitus or chronic obstructive pulmonary disease (COPD) requiring hospitalization within the preceding 6 months.
- Subjects with uncontrolled arterial hypertension, heart failure by New York Heart Association (NYHA) Class 3 or 4, left ventricular ejection fraction (LVEF) < 50% by echocardiography, myocardial infarction, acute coronary syndrome and/or QT prolongations within the preceding 6 months or history of cerebrovascular accidents including episodes of transient ischemic attacks.
- Subjects with altered mental status or psychiatric illness or social circumstances that would limit compliance with the study requirements and/or obscure the results.
- Immunocompromised subjects, e.g., subjects known to be infected with human immunodeficiency virus (HIV) by medical history, and subjects with active hepatitis A, B, or C by medical history.
- Subjects having untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease. (Subjects with treated metastases, who are off corticosteroids and who are neurologically stable for at least 2 months may participate in the trial.)
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 |
|---|---|---|
| TAB08Also: TheralizumabThe initial dose of TAB08 will be 1 µg/kg TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle. | Drug | TAB08( Theralizumab) |
Primary outcome
Number of cases of the Dose-limiting toxicity (DLT)
Time frame: DLT assessment will be performed within first 2 weeks of treatment
6 secondary outcomes
Adverse events (including local reactions) frequency, seriousness and severity
Time frame: Through study completion, not less than 8 weeks
TAB08 concentrations in peripheral blood
Time frame: First 4 weeks of TAB08 administration
Tumor response to TAB08 according to immune-related Response Criteria in Solid Tumors (irRECIST)
Time frame: Through study completion, not less than 12 weeks
Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at designated timepoints comparing to Baseline.
Time frame: Through study completion, not less than 8 weeks
Change of T-lymphocytes subsets in percent in peripheral blood at designated timepoints comparing to Baseline.
Time frame: Through study completion, not less than 8 weeks
Change of cytokines concentrations (in micrograms/mL) in peripheral blood at designated timepoints comparing to Baseline.
Time frame: Through study completion, not less than 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- 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.
Daniil G Nemenov, MD study director
Theramab LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAB08 in people with Solid Tumors, run by Theramab LLC at 1 site in Russia.
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 15 inclusion and 10 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: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of the Dose-limiting toxicity (DLT) (time frame: DLT assessment will be performed within first 2 weeks of treatment). 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 6 Oct 2021.