Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, VBC117, Phase 1, Phase 2a, Dose Escalation
Brief summary
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.
Interventions
DRUGVBC117
VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).
Sponsors
VelaVigo Bio Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study consists of two parts: Phase 1, which employs a sequential BOIN dose-escalation design to evaluate safety and determine the RP2D, and Phase 2a, a parallel-group expansion cohort to assess preliminary anti-tumor activity at the RP2D.
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.
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 EGFR x CDH17 bispecific ADC. 4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload. 5. Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs | From time of Informed Consent to 30 days post last dose of VBC117 | Number of patients with Adverse Events（AEs）by system organ class and preferred term |
| Incidence of DLTs | From time of first dose of VBC117 to end of DLT period (approximately 21 days) | Incidence of dose-limiting toxicities (DLT) as defined in the protocol |
| Incidence of SAEs | From time of Informed Consent to 30 days post last dose of VBC117 | Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term |
| Incidence of TEAE leading to dose modification or discontinuation | From time of Informed Consent to 30 days post last dose of VBC117 | Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term |
| objective response rate (ORR) | From first dose of VBC117 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 |
Countries
Australia, China
Outcome results
None listed