First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
ConditionAdvanced Solid Tumors
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
Male or female adults (defined as ≥ 18 years of age).
Disqualifiers
Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
Known or suspected brain metastases, or spinal cord compression.
Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
Trial design
Design model
Sequential
Treatments tested in this trial
VBC108
DrugVBC108
Treatment groups
230 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: VBC108 Dose Level 1Experimental treatment 1 intervention
Group B: VBC108 Dose Level 2Experimental treatment 1 intervention
Group C: VBC108 Dose Level 3Experimental treatment 1 intervention
Group D: VBC108 Dose Level 4Experimental treatment 1 intervention
Group E: VBC108 Dose Level 5Experimental treatment 1 intervention
Group F: VBC108 Dose Level recommended Phase 2 dose (RP2D)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
From time of first dose of VBC108 to end of DLT period ( 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 VBC1083
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 VBC1084
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 first dose of VBC108 to disease progression or death, up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov