Actively Recruiting
An Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VIB305 in Patients with Advanced Solid Tumors
Led by Vibrant Sciences Limited · Updated on 2026-03-23
146
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of VIB305, an intravenous drug, in adults with advanced solid tumors that cannot be removed by surgery and who have not responded to or cannot undergo standard treatments. This clinical trial is an open-label, non-randomized study with dose-escalation (Phase I) and dose-expansion (Phase II) phases to identify the maximum tolerated dose and recommended dose for further study. Participants receive VIB305 through intravenous infusion once a week, with each treatment cycle lasting three weeks. The study includes six different dose cohorts, with dosing and safety monitored closely during the dose-escalation phase to assess adverse events and dose-limiting toxicities. The dose-expansion phase will further evaluate the drug's safety, pharmacokinetics, immune response, and preliminary anti-tumor activity in selected tumor groups based on earlier results. Throughout the trial, participants will undergo regular assessments including adverse event monitoring, tumor measurements, blood sampling for pharmacokinetic and immunogenicity analysis, and evaluations of treatment response and disease progression. The primary outcomes focus on safety and determining the maximum tolerated dose after the first treatment cycle, while secondary outcomes include immune response, tumor control rates, and pharmacokinetic profiles. Monitoring continues up to 30 days after the last drug administration, with ongoing follow-up to assess treatment effects and participant health.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female
- Histologically or cytologically confirmed advanced solid tumors that are unresectable
- Refractory to, intolerant of, or refuse all existing therapies known to provide clinical benefit
- At least one measurable lesion as assessed by RECIST 1.1
- ECOG performance status score of 0-1
- Estimated survival time of more than 3 months
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test within 72 hours prior to first drug administration
- Females of childbearing potential must agree to abstain or use highly effective contraception from consent until 6 months after last dose
- Male subjects of reproductive capacity must agree to use effective contraception from consent until 6 months after last dose
- Must provide voluntary written informed consent
You will not qualify if you...
- Receipt of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor therapy within 4 weeks prior to first dose
- Receipt of radiotherapy within 4 weeks prior to study treatment or history of radiation pneumonitis
- Receipt of any other investigational drugs within 4 weeks prior to first dose
- Major organ surgery, significant trauma, or requirement for elective surgery within 4 weeks prior to first dose
- Use of systemic glucocorticoids or immunosuppressive agents within 14 days prior to first dose or anticipated need during study
- Use of immunomodulatory agents within 14 days prior to first dose
- Receipt of live or attenuated live vaccine within 4 weeks prior to first dose; inactivated vaccines permitted
- History of prior allogeneic bone marrow or organ transplantation
- Unresolved adverse reactions from prior anti-tumor therapy above Grade 1
- Presence of central nervous system metastasis
- Severe chronic or active infections requiring treatment within 14 days prior to first dose
- Known HIV positivity or AIDS history
- Active hepatitis B infection
- History of other malignancies within past 5 years
- History of severe cardiovascular or cerebrovascular disease
- Clinically significant severe pulmonary dysfunction
- Active or recurrent autoimmune diseases or high risk for recurrence
- Ulcerative, acute, or progressive keratitis
- Severe skin diseases
- Known allergy to any component of the investigational drug
- Prior severe immune-related toxicity from immunotherapy deemed unsuitable for immunotherapy
- Clinically uncontrolled pericardial, pleural, or peritoneal effusions requiring repeated drainage
- Dementia or altered mental status impairing informed consent
- Pregnant or lactating females
- Underlying conditions
- Prior treatment with T cell engager drugs containing CD3 monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive VIB305 by intravenous infusion once every week in treatment cycles of 3 weeks each.
Weekly visits for treatment infusion each cycle
Duration - Up to 30 days after the last treatment
Participants are monitored for safety and response for up to 30 days after the last drug administration.
Approximately 1 to 2 visits after treatment ends
Trial Site Locations
Total: 2 locations
1
Sunshine Coast University Private Hospital
Sunshine Coast, Australia
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
Wenting Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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