Recurrent GlioblastomaPhase 2NCT03856099
TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
A Phase 2 study testing TTAC-0001 in people with Recurrent Glioblastoma, run by PharmAbcine at 3 sites in 2 countries.
Trial summary
This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- TTAC-0001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Nov 2019to 15 Jul 2022
- Phase
- Phase 2
- 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
- Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
- Aged at least 18 years old
- Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
- Patients must have previous treatment including bevacizumab
- Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
- At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria
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- Patients must undergo IDH1 mutational testing on a tumor specimen before entering the study. Immunohistochemistry (IHC) is sufficient for enrollment, although DNA sequencing may also be performed as per local institutional guidelines. Patients are eligible regardless of their tumor status.
- Karnofsky Performance Status (KPS) ≥ 70
- A person who satisfies the following criteria in hematologic, renal, and hepatic function tests (1) Hematologic tests - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelets ≥ 75 x 109/L
- Hemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests
- Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (ULN)
- Activated partial thromboplastin Time (aPTT) ≤ 1.5 x ULN (3) Hepatic function tests
- Total bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x ULN (4) Renal function test
- Creatinine clearance (CrCl) ≥ 30 mL/minute calculated by Cockcroft-Gault formula
- Life expectancy of at least 12 weeks
- Females of child bearing potential must have a negative pregnancy test during screening and must not be breastfeeding or intending to become pregnant during the study.
- Male patients with female partners of child-bearing potential must be willing to use two forms of acceptable contraception, including one barrier method, during their participation in this study and for 16 weeks following the last dose of the study. Refer to section 10.5.1 Restrictions, permitted methods of contraception and definitions.
Who cannot join
- Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to receiving the first dose of treatment.
- The following concomitant diseases:
- Uncontrolled hypertension (systolic blood pressure [SBP] > 150 or diastolic blood pressure [DBP] > 90 mmHg) (2) Uncontrolled seizures (3) Class III or IV heart failure according to New York Heart Association (NYHA) classification (4) Oxygen-dependent chronic disease (5) Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
- 3) Not recovered from AEs < National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 2 caused by CCRT 4) Treatment with bevacizumab including therapy 2 weeks prior to receiving the first dose of treatment.
- 5) Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery) 6) Treated with other investigational products within 4 weeks prior to the patient receiving the first dose of treatment.
- 7) A known history of severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug 8) Unable to participate in the trial according to the investigator's decision. 9) Patient not eligible for sequential MRI evaluations are not eligible for this study 10) Previous therapy with VEGF-targeted agents except bevacizumab. 11) Known active hepatitis B or hepatitis C infection 12) Has received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
- 13) Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Florida Hospital Cancer Institute & Florida Hospital Orlando
Orlando, Florida, 32804
Stanford Avanced Medical Center
Stanford, California, 94305
About this study
Official title: A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
This is a phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.
- Conditions
- Recurrent Glioblastoma
- Being tested
- TTAC-0001
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTAC-0001Drug
- Investigational product (IP): TTAC-0001
- Treatment groups: 3 dose groups
- Dose group A : TTAC-0001 16 mg/kg on D1 and D15
- Dose group B : TTAC-0001 20 mg/kg on D1 and D15
- Dose group C : TTAC-0001 24 mg/kg on D1 and D15
- Cycle: 4 weeks (28 days per cycle)
| Study group | Role | What they receive |
|---|---|---|
| TTAC-0001 | Experimental | TTAC-0001 with dose assigned to each dose group will be administered Receives: Drug: TTAC-0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The frequency and percentage of AEs will be presented by dose goup
Measured: until time of progressive disease or 1 year
Secondary outcomes (6)
Progression free survival rate at 4 months
The rate and 2-sided 95% confidence interval of progression free survival at the 4-month
Measured: at the end of 4 months
Progression free survival rate at 6 months
The rate and 2-sided 95% confidence interval of progression free survival at the 6-month
Measured: at the end of 6 months
Progression free survival
Period from the date of the drug administration to the disease progression time point
Measured: until time of progressive disease or time point of patients' death which come first assessed up to 1 year
Overall survival
Period from the date of the drug administration to the time point of patient's death
Measured: until time point of patients' death up to 1 year
Objective response rate
complete response (CR) or partial response (PR) by RANO criteria
Measured: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)
Disease control rate
complete response (CR), partial response (PR) or stable disease (SD) by RANO criteria
Measured: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start13 Nov 2019
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Why it stopped: Subject recruitment issues and follow-up study plans
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAbcine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856099
- Sponsor's protocol ID
- PMC_TTAC-0001_03
- Status last verified
- Aug 2022
- First submitted
- 21 Feb 2019
- Last updated
- 18 Aug 2022
- Results posted
- No
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
- ClinicalTrials.gov ID
- NCT03856099
- Acronym / sponsor ID
- PMC_TTAC-0001_03
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment issues and follow-up study plans
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PharmAbcineIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Feb 2019 (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 phase II, open-Label clinical trial to evaluate the safety and efficacy of TTAC-0001 in patients with recurrent glioblastoma who was progressed on bevacizumab including therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTAC-0001 | Experimental | Drug: TTAC-0001TTAC-0001 with dose assigned to each dose group will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses.
- Aged at least 18 years old
- Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma
- Patients must have previous treatment including bevacizumab
- Patients must have a radiological diagnosis of recurrent/relapsed or progressive glioblastoma/gliosarcoma after bevacizumab including therapy according to response assessment in neuro-oncology (RANO) criteria
Key exclusion criteria (7 listed)
- Diagnosed with malignant tumors, except basal cell carcinoma, cutaneous squamous cell carcinoma, and noninvasive uterine cervical cancer treated within 2 years prior to receiving the first dose of treatment.
- The following concomitant diseases:
- Uncontrolled hypertension (systolic blood pressure [SBP] > 150 or diastolic blood pressure [DBP] > 90 mmHg) (2) Uncontrolled seizures (3) Class III or IV heart failure according to New York Heart Association (NYHA) classification (4) Oxygen-dependent chronic disease (5) Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion.
- 3) Not recovered from AEs < National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 2 caused by CCRT 4) Treatment with bevacizumab including therapy 2 weeks prior to receiving the first dose of treatment.
- 5) Undergone major surgery requiring general anesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit (within 2 weeks for video-assisted thoracoscopic surgery [VATS] or open-and-closed [ONC] surgery) 6) Treated with other investigational products within 4 weeks prior to the patient receiving the first dose of treatment.
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 |
|---|---|---|
| TTAC-0001* Investigational product (IP): TTAC-0001 * Treatment groups: 3 dose groups * Dose group A : TTAC-0001 16 mg/kg on D1 and D15 * Dose group B : TTAC-0001 20 mg/kg on D1 and D15 * Dose group C : TTAC-0001 24 mg/kg on D1 and D15 * Cycle: 4 weeks (28 days per cycle) | Drug | TTAC-0001 |
Primary outcome
Adverse Events
Time frame: until time of progressive disease or 1 year
The frequency and percentage of AEs will be presented by dose goup
6 secondary outcomes
Progression free survival rate at 4 months
Time frame: at the end of 4 months
Progression free survival rate at 6 months
Time frame: at the end of 6 months
Progression free survival
Time frame: until time of progressive disease or time point of patients' death which come first assessed up to 1 year
Overall survival
Time frame: until time point of patients' death up to 1 year
Objective response rate
Time frame: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)
Disease control rate
Time frame: At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (every cycle is 28 days)
Results and safety
The study was stopped early (reason given: Subject recruitment issues and follow-up study plans). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTAC-0001 in people with Recurrent Glioblastoma, run by PharmAbcine at 3 sites in 2 countries.
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 18 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Subject recruitment issues and follow-up study plans). Results are not available in the source record.
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?
Adverse Events (time frame: until time of progressive disease or 1 year). 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 18 Aug 2022.