First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- VBC108
Treatment groups
230 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov