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This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify 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 VBC101.
Protocol Version：V1.2 Version Date：2025-11-12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBC101 | Drug | VBC101 |
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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 | (DLT)From time of first dose of VBC101 to end of DLT period (approximately 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 VBC101 |
| 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 VBC101 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
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Inclusion Criteria:
Exclusion Criteria:
1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Li | Contact | +86 13681943496 | chen.li@velavigo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Start Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Duration of Response (DoR) |
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression |
| From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) |
| Disease Control Rate (DCR) at 12 weeks | The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for >=11 weeks from first dose | From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks) |
| Progression free Survival (PFS) | The time from first dose until RECIST 1.1 defined disease progression or death due to any cause | From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years) |
| Overall Survival (OS) | The time from the date of the first dose of study treatment until death due to any cause. | From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years) |
| Pharmacokinetics of VBC101: Plasma PK concentrations | Measurement of plasma concentrations of VBC101, total antibody and total unconjugated warhead | From date of first dose of VBC101 up until 30 days post last dose |
| Pharmacokinetics of VBC101: Area under the concentration time curve (AUC) | Measurement of PK parameters: Area under the concentration time curve (AUC) | From date of first dose of VBC101 up until 30 days post last dose |
| Pharmacokinetics of VBC101: Maximum plasma concentration of the study drug (C-max) | Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) | From date of first dose of VBC101 up until 30 days post last dose |
| Pharmacokinetics of VBC101: Time to maximum plasma concentration of the study drug (T-max) | Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) | From date of first dose of VBC101 up until 30 days post last dose |
| Pharmacokinetics of VBC101: Half-life | Measurement of PK parameters: Terminal elimination half-life (t 1/2) | From date of first dose of VBC101 up until 30 days post last dose |
| Immunogenicity of VBC101: Anti-Drug Antibodies (ADA) | Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment | From date of first dose of VBC101 up until 30 days post last dose |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| START Mountain Region, LLC. | Recruiting | West Valley City | Utah | 84119 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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