Actively Recruiting
A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
Led by Vibrant Sciences Limited · Updated on 2026-03-23
146
Participants Needed
2
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard treatments or refused the existing treatments. This study is divided into a dose-escalation phase (Phase I) and a dose-expansion phase (Phase II). Phase I (dose escalation) is designed to preliminarily evaluate the safety and tolerability of VIB305 in advanced solid tumors, to determine the nature and incidence of dose-limiting toxicities (DLTs), and thereby to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Based on the findings from the Phase I portion for evaluation in the Phase II portion. Phase II (dose expansion) will enroll additional cohorts to further assess the safety and tolerability, PK profile, preliminary antitumor activity and immunogenicity of VIB305 in specific tumor types (selected based on all available data).
CONDITIONS
Official 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...
- Age 18 years or older, any gender
- Histologically or cytologically confirmed advanced solid tumors that are unresectable
- Tumors that are resistant to, intolerant of, or refuse existing effective therapies
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Estimated life expectancy of more than 3 months
- Adequate organ function
- Negative pregnancy test within 72 hours before first dose for females of childbearing potential
- Females of childbearing potential must agree to abstain or use highly effective contraception from consent until 6 months after last dose
- Male participants of reproductive potential must agree to use effective contraception from consent until 6 months after last dose
- Signed informed consent prior to participation
You will not qualify if you...
- Use of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor treatments within 4 weeks before first dose
- Radiotherapy within 4 weeks before starting treatment or history of radiation pneumonitis
- Use of any other investigational drugs not yet marketed within 4 weeks before first dose
- Major surgery, significant trauma, or need for elective surgery within 4 weeks before first dose
- Use of systemic glucocorticoids or immunosuppressive agents within 14 days before first dose or expected use during study
- Use of immunomodulatory agents such as thymosin, interleukin-2, interferons within 14 days before first dose
- Receipt of live or attenuated live vaccines within 4 weeks before first drug use (inactivated vaccines allowed)
- History of allogeneic bone marrow or organ transplantation
- Unresolved adverse reactions from prior anti-tumor therapy above Grade 1
- Presence of central nervous system metastases
- Severe chronic or active infections requiring systemic treatment within 14 days before first dose
- Known HIV infection or AIDS
- Active hepatitis B infection
- History of other cancers within the past 5 years
- Severe cardiovascular or cerebrovascular disease
- Clinically significant severe lung 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 immunotherapy with severe immune-related toxicity deemed unsuitable
- Uncontrolled pericardial, pleural, or peritoneal fluid requiring repeated drainage
- Dementia or altered mental state affecting informed consent
- Pregnant or breastfeeding females
- Other underlying conditions deemed unsuitable
- Prior treatment with CD3 monoclonal antibody-containing T cell engager drugs
AI-Screening
AI-Powered Screening
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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
CONTACT
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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