Advanced Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGVBC108
VBC108
Sponsors
VelaVigo Bio Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | From time of first dose of VBC108 to end of DLT period ( 21 days) | Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol |
| Incidence of Serious Adverse Events | From time of Informed Consent to 30 days post last dose of VBC108 | Number of patients with serious adverse events by system organ class and preferred term |
| Incidence of Adverse Events (AEs) | From time of Informed Consent to 30 days post last dose of VBC108 | Number of patients with adverse events by system organ class and preferred term |
| Objective Response Rate (ORR) | From first dose of VBC108 to disease progression or death, up to approximately 2 years | 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) |
Countries
Australia, China, United States
Contacts
CONTACTJun Yan
Outcome results
None listed