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This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB263T | Experimental | Experimental: GB263T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB263T | Biological | Participants will receive IV infusions of GB263T at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs | Screening up to follow-up (30 [+7] days after the last dose) | |
| DLT in Phase I | During Cycle 1 (up to 28 days) | |
| ORR in Phase II | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | At predefined intervals up to 449 days | |
| Tmax | At predefined intervals up to 449 days | |
| AUC0-last |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Yu, MD | Contact | 021-60751991 | shawn.yu@genorbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Care | Recruiting | Saint Leonards | New South Wales | 2065 | Australia | |
| Westmead Hospital |
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| At predefined intervals up to 449 days |
| AUC0-τ | At predefined intervals up to 449 days |
| t1/2 | At predefined intervals up to 449 days |
| Cmin | At predefined intervals up to 449 days |
| Rac_Cmax | At predefined intervals up to 449 days |
| Rac_AUC0-τ | At predefined intervals up to 449 days |
| ADA | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| PFS | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose |
| DOR | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| CBR | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| OS | Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose) |
| Recruiting |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| Cabrini Hospital Malvern | Recruiting | Malvern | Victoria | 3144 | Australia |
| St Vincent's Hospital Melbourne | Recruiting | Melbourne | Victoria | 3065 | Australia |