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

NCT03856099 | Terminated Phase 2 FDA Drug

• 1 other identifier: PMC_TTAC-0001_03
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  The frequency and percentage of AEs will be presented by dose goup

  until time of progressive disease or 1 year

Secondary Outcomes (6)

• Progression free survival rate at 4 months

  at the end of 4 months

• Progression free survival rate at 6 months

  at the end of 6 months

• Progression free survival

  until time of progressive disease or time point of patients' death which come first assessed up to 1 year

• Overall survival

  until time point of patients' death up to 1 year

• Objective response rate

  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)

Other Outcomes (11)

• Immunogenicity

  From screening visit to end of treatment visit (time of progressive disease or 1 year)

• Pharmacokinetic parameters - Cmax

  From screening visit to end of treatment visit (time of progressive disease or 1 year)

• Pharmacokinetic parameters - Cmin

  From screening visit to end of treatment visit (time of progressive disease or 1 year)

Study Arms (1)

TTAC-0001

EXPERIMENTAL

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

Drug: TTAC-0001

Interventions

TTAC-0001 DRUG

* 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)

TTAC-0001

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• \) 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.
• \) 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.
• \) 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.
• \) Has had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment

Sponsors & Collaborators

• PharmAbcine: lead

Study Sites (3)

Stanford Avanced Medical Center

Stanford, California, 94305, United States

Location

Florida Hospital Cancer Institute & Florida Hospital Orlando

Orlando, Florida, 32804, United States

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

olinvacimab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 27, 2019
• Study Start: November 13, 2019
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (1)