Participants With Advanced Solid Tumor Malignancies
Conditions
Brief summary
This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.
Detailed description
Protocol Version：V1.1 Version Date：2025-12-12
Interventions
DRUGVBC103
VBC103
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
* 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures. * 2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5). * 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1. * 4.Adult male or female (defined as ≥18 years of age) * 5.ECOG performance status score of 0-1. * 6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment. * 7.Life expectancy exceeding 12 weeks. * 8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.
Exclusion criteria
* 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy. * 2.Known active keratitis or corneal ulcer. * 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung disease based on imaging during the screening period. * 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant pulmonary impairment or requiring supplemental oxygen, as well as any autoimmune, connective tissue, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and/or prior pneumonectomy (complete resection).
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 VBC103 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 VBC103 | Number of patients with serious adverse events by system organ class and preferred term |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From date of first dose of VBC103 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 VBC103 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 VBC103 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 |
| Pharmacokinetics of VBC103: Plasma PK concentrations | From date of first dose of VBC103 up until 30 days post last dose | Measurement of plasma concentrations of VBC103, total antibody and total unconjugated warhead |
| Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max) | From date of first dose of VBC103 up until 30 days post last dose | Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max) |
| Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max) | From date of first dose of VBC103 up until 30 days post last dose | Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max) |
| Immunogenicity of VBC103: Anti-Drug Antibodies (ADA) | From date of first dose of VBC103 up until 30 days post last dose | Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment |
Countries
China
Contacts
CONTACTJian Zhang
Outcome results
None listed