TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent prior to any study specific procedures, sampling or analyses. 2. Aged at least 18 years old 3. Patients must have a histologically proven diagnosis of glioblastoma/gliosarcoma 4. Patients must have previous treatment including bevacizumab 5. 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 6. At least one confirmed measurable lesion or non measurable lesion as determined by RANO criteria 7. 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. 8. Karnofsky Performance Status (KPS) ≥ 70 9. 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 10.
Life expectancy of at least 12 weeks 11. 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. 12. 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.

Exclusion Criteria:

1. 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. 2. The following concomitant diseases:
  • (1) 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03856099
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

PharmAbcine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: TTAC-0001

TTAC-0001 with dose assigned to each dose group will be administered

Interventions

Drug: - 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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Avanced Medical Center, Stanford, California

Status

Recruiting

Address

Stanford Avanced Medical Center

Stanford, California, 94305

Site Contact

Hary Priya Yerraballa

sylee@pharmabcine.com

650-724-9363

Orlando, Florida

Status

Recruiting

Address

Florida Hospital Cancer Institute & Florida Hospital Orlando

Orlando, Florida, 32804

Site Contact

Andrea Thomas

sylee@pharmabcine.com

407-303-7376

International Sites

Austin Hospital, Heidelberg, Victoria, Australia

Status

Recruiting

Address

Austin Hospital

Heidelberg, Victoria, 3084

Site Contact

Kate Fluck

sylee@pharmabcine.com

+61 3 9496 9912

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