First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Официальное название

PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES

Обзор

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.

Подробное описание

Protocol Version：V1.3 Version Date：2026-04-20

Вмешательства

• Препарат VBC101
  VBC101

Первичные конечные точки

• Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Срок оценки: (DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)]
• Incidence of Serious Adverse Events [Срок оценки: From time of Informed Consent to 30 days post last dose of VBC101]
• Incidence of Adverse Events (AEs) [Срок оценки: From time of Informed Consent to 30 days post last dose of VBC101]

Вторичные конечные точки (11)

• Objective Response Rate (ORR) [Срок оценки: From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
• Duration of Response (DoR) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)]
• Overall Survival (OS) [Срок оценки: 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 [Срок оценки: From date of first dose of VBC101 up until 30 days post last dose]
• Pharmacokinetics of VBC101: Area under the concentration time curve (AUC) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From date of first dose of VBC101 up until 30 days post last dose]
• Pharmacokinetics of VBC101: Half-life [Срок оценки: From date of first dose of VBC101 up until 30 days post last dose]
• Immunogenicity of VBC101: Anti-Drug Antibodies (ADA) [Срок оценки: From date of first dose of VBC101 up until 30 days post last dose]

Критерии участия

Критерии включения

A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:

• 1\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
• 2\. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
• 3\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
• 4\. Male or female adults (defined as ≥ 18 years of age)
• 5\. ECOG performance status 0-1
• 6\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
• 7\. Life expectancy greater than 12 weeks
• 8\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
• 9\. Adequate organ and bone marrow function
• 10\. Participants must meet the minimum washout period requirements before the first dose of investigational drug

Критерии исключения

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.

• 2\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
• 3\. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
• 4\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
• 5\. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Start Midwest — Grand Rapids
• The University of Texas MD Anderson Cancer Center — Houston
• NEXT Oncology — San Antonio
• START Mountain Region, LLC. — West Valley City
• NEXT Virginia — Fairfax

Идентификаторы

NCT: NCT07136779 · VBC101-01-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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