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This is a Phase 1/2 study of GB261 in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage(Phase 1), an expansion stage(Phase 2a) and Phase 2b stage where participants will be enrolled into indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB261 | Experimental | Participants will receive GB261 via intravenous (IV) infusion as a single agent on Day 1, Day 8 and Day 15 of Cycle 1 and 2 followed by Day 1 of each cycle(21 days per cycle) afterwards until disease progression or other situations specified in the protocol, whichever comes earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB261 | Biological | Drug:GB261 IV, participants with B-cell NHL or CLL will receive GB261 via IV infusion weekly for the first two cycles(1cycle=21days), followed by Q3W from C3 and afterwards in given doses until progression disease or other situations specified in the protocol, whichever comes earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | During Cycle 1 (up to 21 days) | |
| Dose Limiting Toxicity | During Cycle 1 (up to 21 days) | |
| Percentage of participants with adverse events | From first dosing until 90 days after the last treatment | |
| Objective Response Rate | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | At predefined intervals up to 106 days | |
| Tmax | At predefined intervals up to 106 days | |
| Area Under the Curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Yu, MD | Contact | 021-60751991 | shawn.yu@genorbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital/The Kinghorn Cancer Centre | Recruiting | Sydney | New South Wales | 2010 | Australia | |
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|
| At predefined intervals up to 106 days |
| t1/2 | At predefined intervals up to 106 days |
| Clearance | At predefined intervals up to 106 days |
| Vz | At predefined intervals up to 106 days |
| Anti-Drug Antibody | At predefined intervals up to 3 years |
| Progression Free Survival | Through study completion, an average of 3 years |
| Duration of Objective Response | Through study completion, an average of 3 years |
| Duration of Objective Complete Response | Through study completion, an average of 3 years |
| Overall Survival | Through study completion, an average of 3 years |
| Royal Adelaide Hospital |
| Recruiting |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Cabrini hospital | Recruiting | Melbourne | The State of Victoria | 3144 | Australia |
| Alfred hospital | Recruiting | Melbourne | The State of Vitoria | 3004 | Australia |
| Peninsula & South Eastern Haematology & Oncology Group | Terminated | Melbourne | The State of Vitoria | 3199 | Australia |
| One Clinical Research Pty Ltd | Recruiting | Mount Pleasant | Western Australia | 6153 | Australia |