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This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
See above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | ANG1005 administered to bevacizumab-naive recurrent GBM participants |
|
| Arm 2 | Experimental | ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants |
|
| Arm 3 | Experimental | ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANG1005 | Drug | ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (Arms 1 and 3) | To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma World Health Organization (WHO) Grade III patients (Arm 3) | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| PFS3 (Arm 2) | To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2) | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in Arm 2 | To determine the ORR in Arm 2 | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| PFS at 3, 6 and 12 months |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty Lawrence | Angiochem Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UC San Diego Cancer Center | La Jolla | California | 92093-0698 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39713041 | Derived | Dmello C, Brenner A, Piccioni D, Wen PY, Drappatz J, Mrugala M, Lewis LD, Schiff D, Fadul CE, Chamberlain M, Kesari S, Ahluwalia M, Ghosh D, Sonabend AM, Kumthekar P. Phase II trial of blood-brain barrier permeable peptide-paclitaxel conjugate ANG1005 in patients with recurrent high-grade glioma. Neurooncol Adv. 2024 Dec 14;6(1):vdae186. doi: 10.1093/noajnl/vdae186. eCollection 2024 Jan-Dec. |
| Label | URL |
|---|---|
| A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant glioma | View source |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C531859 | paclitaxel-Angiopep-2 conjugate |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion. |
|
|
| Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Median PFS | To determine the median progression-free survival in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Duration of response | To determine the median duration of response in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Overall survival | To determine the median overall survival in each arm | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Safety and tolerability | To determine the number of participants with adverse events | Upon enrollment through end of study period (1 year after last patient is enrolled) |
| Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC]) | To determine the drug concentration and distribution in the blood (plasma) | At 0 h (pre-dose), at the end of infusion, at 2 and 4 hours post-dose on Day 1 of treatment cycles 1 and 3 (Week 1 and Week 9) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15323 | United States |
| Univeristy of Texas Health Science Center in San Antonio | San Antonio | Texas | 78229 | United States |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |