Health Trials

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 groups

6

Treatment groups

See each treatment group below.

Locations

12
Australia
GenesisCare North Shore2065, St LeonardsNew South Wales, Australia
One Clinical Research6009, PerthWestern Australia, Australia
China
Beijing Cancer Hospital100142, BeijingBeijing Municipality, China
Beijing GoBroad Hospital102200, BeijingBeijing Municipality, China

Sponsors and collaborators

VelaVigo Bio Inc

Lead sponsor

Source ClinicalTrials.gov