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This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBC108 Dose Level 1 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 1 |
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| VBC108 Dose Level 2 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 2 |
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| VBC108 Dose Level 3 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 3 |
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| VBC108 Dose Level 4 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 4 |
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| VBC108 Dose Level 5 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 5 |
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| VBC108 Dose Level recommended Phase 2 dose (RP2D) | Experimental | Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBC108 | Drug | VBC108 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol | From time of first dose of VBC108 to end of DLT period ( 21 days) |
| Incidence of Serious Adverse Events | Number of patients with serious adverse events by system organ class and preferred term | From time of Informed Consent to 30 days post last dose of VBC108 |
| Incidence of Adverse Events (AEs) | Number of patients with adverse events by system organ class and preferred term | From time of Informed Consent to 30 days post last dose of VBC108 |
| Objective Response Rate (ORR) | The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1) | From first dose of VBC108 to disease progression or death, up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Yan | Contact | 15800359085 | jun.yan@VelaVigo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| START Midwest, LLC | Grand Rapids | Michigan | 49546 | United States |
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| Laura and Issac Perlmutter Cancer Center | New York | New York | 10016 | United States |
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| Next Oncology - Oncology | San Antonio | Texas | 78229 | United States |
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| NEXT Oncology Virginia | Fairfax | Virginia | 22031 | United States |
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| GenesisCare North Shore | St Leonards | New South Wales | 2065 | Australia |
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| One Clinical Research | Perth | Western Australia | 6009 | Australia |
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| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 102200 | China |
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| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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