First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVelaVigo Bio Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
VBC101
DrugVBC101
Treatment groups
310 Participants
are divided into 1 treatment groupGroup A: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
(DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)2
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Time frame
From time of Informed Consent to 30 days post last dose of VBC1013
Incidence of Adverse Events(AEs)
Number of patients with adverse events by system organ class and preferred term
Time frame
From time of Informed Consent to 30 days post last dose of VBC101Secondary outcomes
1
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)
Time frame
From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)2
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
Time frame
From date of first dose of VBC101 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)3
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
Time frame
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)4
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Time frame
From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)Sponsors and contacts
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Source ClinicalTrials.gov