Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVelaVigo Bio Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
VBC103
DrugVBC103
Treatment groups
255 Participants
are divided into 1 treatment groupGroup A: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Time frame
(DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)2
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Time frame
From time of Informed Consent to 30 days post last dose of VBC103Secondary outcomes
1
Objective Response Rate (ORR)
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)
Time frame
From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)2
Duration of Response (DOR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Time frame
From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)3
Disease Control Rate (DCR) 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
Time frame
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)4
Pharmacokinetics of VBC103: Plasma PK concentrations
Measurement of plasma concentrations of VBC103, total antibody and total unconjugated warhead
Time frame
From date of first dose of VBC103 up until 30 days post last doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov