Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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 . 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria. 4. Male or female adults (defined as ≥ 18 years of age). 5. ECOG performance status 0-1. 6. Life expectancy greater than 12 weeks. 7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection. 8. Adequate organ and bone marrow function. 9. Participants must meet the minimum washout period requirements before the first dose of investigational drug.

Exclusion Criteria

  1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment. 2. Known or suspected brain metastases, or spinal cord compression. 3. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC. 4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload. 5. Prior treatment with CLDN18.2 targeting CAR-T.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VBC108 Dose Level 1 		Phase 1 dose escalation and backfill: VBC108 at Dose Level 1
  • Drug: VBC108
    VBC108
Experimental
VBC108 Dose Level 2 		Phase 1 dose escalation and backfill: VBC108 at Dose Level 2
  • Drug: VBC108
    VBC108
Experimental
VBC108 Dose Level 3 		Phase 1 dose escalation and backfill: VBC108 at Dose Level 3
  • Drug: VBC108
    VBC108
Experimental
VBC108 Dose Level 4 		Phase 1 dose escalation and backfill: VBC108 at Dose Level 4
  • Drug: VBC108
    VBC108
Experimental
VBC108 Dose Level 5 		Phase 1 dose escalation and backfill: VBC108 at Dose Level 5
  • Drug: VBC108
    VBC108
Experimental
VBC108 Dose Level recommended Phase 2 dose (RP2D) 		Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts
  • Drug: VBC108
    VBC108

Recruiting Locations

City of Hope Medical Center
Duarte, California 91010
Contact:
Dani Castillo, MD
6262182123
dacastillo@coh.org

START Midwest, LLC
Grand Rapids, Michigan 49546
Contact:
Sreenivasa Chandana
16169545554
sreenivasa.chandana@startmidwest.com

Next Oncology - Oncology
San Antonio, Texas 78229
Contact:
David Sommerhalder
2105809500
dsommerhalder@nextoncology.com

NEXT Oncology Virginia
Fairfax, Virginia 22031
Contact:
Mohamad Salkeni
7032083159
mohamad.salkeni@usoncology.com

More Details

Status
Recruiting
Sponsor
VelaVigo Bio Inc

Study Contact

Jun Yan
15800359085
jun.yan@VelaVigo.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.