Participants With Advanced Solid Tumor Malignancies
Conditions
Brief summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts BOIN design to identify 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 VBC106.
Interventions
DRUGVBC106
VBC106
Sponsors
VelaVigo Bio Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- A participant must meet all of the following inclusion criteria to be eligible to participate in this trial: * 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 that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or standard therapies are not appropriate or not safe in the opinion of the Investigator or refused by the participant. * 3\. At least one measurable lesion as assessed according to RECIST v1.1 criteria for participants with non-pleural mesothelioma or other solid tumors and modified RECIST(mRECIST) for participants with malignant pleural mesothelioma. * 4\. Male or female adults (defined as ≥ 18 years of age) * 5\. ECOG performance status 0-1 * 6\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment. * 7\. Life expectancy greater than 12 weeks * 8\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection. * 9\. 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. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening. 4. Has a history of underlying pulmonary disorder including. 5. History of chronic, active, or hereditary corneal disease. 6. Participant history of congestive heart failure (CHF) Class II-IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLT) as defined in the protocol | (DLT)From time of first dose of VBC106 to end of DLT period (approximately 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 VBC106 | 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 VBC106 | Number of patients with adverse events by system organ class and preferred term |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (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) |
| Duration of Response (DoR) | From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years) | The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression |
| Disease Control Rate (DCR) at 12 weeks | From date of first dose of VBC106 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks) | The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \>=11 weeks from first dose |
| Progression free Survival (PFS) | From date of first dose of VBC106 up until date of progression or death due to any cause (approximately 2 years) | The time from first dose until RECIST 1.1 defined disease progression or death due to any cause |
| Overall Survival (OS) | From date of first dose of VBC106 up until the date of death due to any cause (approximately 2 years) | The time from the date of the first dose of study treatment until death due to any cause. |
| Pharmacokinetics of VBC106 | From date of first dose of VBC106 up until 30 days post last dose | Measurement of plasma concentrations of VBC106, total antibody and total unconjugated warhead(measurement unit can be same as ng/ml) |
| Pharmacokinetics of VBC106: Area under the concentration time curve (AUC) | From date of first dose of VBC106 up until 30 days post last dose | Measurement of PK parameters: Area under the concentration time curve (AUC) |
| Pharmacokinetics of VBC106: Maximum plasma concentration of the study drug (C-max) | From date of first dose of VBC106 up until 30 days post last dose | Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) |
| Pharmacokinetics of VBC106: Time to maximum plasma concentration of the study drug (T-max) | From date of first dose of VBC106 up until 30 days post last dose | Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) |
| Pharmacokinetics of VBC106: Half-life | From date of first dose of VBC106 up until 30 days post last dose | Measurement of PK parameters: Terminal elimination half-life (t 1/2) |
| Immunogenicity of VBC106: Anti-Drug Antibodies (ADA) | From date of first dose of VBC106 up until 30 days post last dose | Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment |
Countries
Australia, United States
Contacts
CONTACTFeng Guo
Outcome results
None listed