VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVelaVigo Bio Inc

About this trial

Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.

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 EGFR x CDH17 bispecific ADC.

Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.

Trial design

Treatments tested in this trial

  • VBC117

Treatment groups

260 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators