Advanced Solid TumorsPhase 1/2NCT07222969
A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing VIB305 for Injection in people with Advanced Solid Tumors, run by Vibrant Sciences Limited at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- VIB305 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jan 2026to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, male or female.
- Subjects with histologically or cytologically confirmed advanced solid tumors that are unresectable, who are refractory to or intolerant of or refuse all existing therapy(ies) known to provide clinical benefit for their condition.
- 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.
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- Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to first administration of the investigational drug. Females of childbearing potential must agree to abstain or use highly effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
- Male subjects of reproductive capacity must agree to use effective contraception from the time of signing informed consent form until 6 months after their last dose of the investigational drug.
- Subjects must be fully informed about this study before participation and must voluntarily sign a written informed consent form.
Who cannot join
- Receipt of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor therapy within 4 weeks prior to first dose of investigational drug.
- Receipt of radiotherapy within 4 weeks prior to initiation of study treatment, or history of radiation pneumonitis.
- Receipt of any other investigational drugs not yet marketed within 4 weeks prior to first dose of investigational drug.
- Receipt of major organ surgery or occurrence of significant trauma, or requirement for elective surgery during the study, within 4 weeks prior to first dose of investigational drug.
- Use of systemic glucocorticoids or other immunosuppressive agents within 14 days prior to the first dose of investigational drug or anticipated need during the study.
- Use of immunomodulatory agents, including but not limited to thymosin, interleukin-2, interferons, etc., within 14 days prior to first administration of investigational drug.
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- Receipt of live vaccine or attenuated live vaccine within 4 weeks prior to first use of investigational drug. Inactivated vaccines are permitted.
- History of prior allogeneic bone marrow transplantation or organ transplantation.
- Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 based on CTCAE v5.0.
- Subjects with central nervous system (CNS) metastasis.
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.
- Known history of human immunodeficiency virus (HIV) positivity or history of acquired immunodeficiency syndrome (AIDS).
- Subjects with active hepatitis B virus (HBV) infection.
- History of other malignancies within the past 5 years.
- History of severe cardiovascular or cerebrovascular disease.
- Clinically significant severe pulmonary dysfunction.
- Subjects with active or recurrent autoimmune diseases, or a related history and high risk for recurrence, or subjects at high risk.
- Subjects with ulcerative keratitis, acute keratitis, or progressive keratitis.
- Subjects with severe skin diseases.
- Known hypersensitivity or allergy to any component of the investigational drug.
- Prior receipt of immunotherapy, with severe immune-related toxicity regardless of remission status, as determined by the investigator to be unsuitable for immunotherapy.
- Clinically uncontrolled pericardial, pleural, or peritoneal effusions requiring repeated drainage.
- Dementia or altered mental status that may impair understanding and provision of informed consent form.
- Pregnant or lactating females.
- Underlying conditions.
- Prior receipt of treatment with T cell engager drugs containing CD3 monoclonal antibodies.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Sunshine Coast University Private Hospital
Sunshine Coast
Andrew Schmidt
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang
About this study
Official title: An Open-label, Dose-escalation and Dose-expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of VIB305 in Patients With Advanced Solid Tumors
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
- Advanced Solid Tumors
- Being tested
- VIB305 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIB305 for InjectionDrug
Intravenous infusion: once every week, each treatment cycle is 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VIB305 for Injection in Cohort 1 | Experimental | VIB305 for Injection does in Cohort 1 according to protocol Receives: Drug: VIB305 for Injection |
| VIB305 for Injection in Cohort 2 | Experimental | VIB305 for Injection does in Cohort 2 according to protocol Receives: Drug: VIB305 for Injection |
| VIB305 for Injection in Cohort 3 | Experimental | VIB305 for Injection does in Cohort 3 according to protocol Receives: Drug: VIB305 for Injection |
| VIB305 for Injection in Cohort 4 | Experimental | VIB305 for Injection does in Cohort 4 according to protocol Receives: Drug: VIB305 for Injection |
| VIB305 for Injection in Cohort 5 | Experimental | VIB305 for Injection does in Cohort 5 according to protocol Receives: Drug: VIB305 for Injection |
| VIB305 for Injection in Cohort 6 | Experimental | VIB305 for Injection does in Cohort 6 according to protocol Receives: Drug: VIB305 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and/or RP2D based on the incidence and nature of DLTs
Incidence of dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 21 days)
Adverse events（AE）
Include SAEs, TEAEs
Measured: From signed ICF to 30 days after the last drug administration
Secondary outcomes (9)
The immunogenicity of VIB305
Specification and quantification of ADAs or NAb
Measured: Pre-dose of Cycle 1, Cycle 1 Day 15, pre-dose of Cycle 2, Cycle 2 Day 15, pre-dose of Cycle 3, Cycle 4 and following cycle(each cycle is 21 days) , 30 days after the last administration, 90 days after the last administration
Objective response rate (ORR)
The proportion of subjects who achieved a confirmed response of complete response (CR) or partial response [PR]
Measured: From signed ICF to 30 days after the last drug administration
Duration of response (DOR)
The time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD)
Measured: From signed ICF to 30 days after the last drug administration
Disease control rate(DCR)
The proportion of patients who achieved complete response (CR), partial response (PR), and stable lesion (SD) after tumor treatment and could maintain the minimum duration requirement
Measured: From signed ICF to 30 days after the last drug administration
Progression-free survival (PFS)
The time from the date of enrollment to the earlier of the dates of the first objective documentation of radiographic PD based on RECIST version 1.1 or death due to any cause
Measured: From signed ICF to 30 days after the last drug administration
The pharmacokinetics (PK) profile of VIB305（Maximum concentration (Cmax)）
Maximum concentration (Cmax)
Measured: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Time of Cmax (Tmax)）
Time of Cmax (Tmax)
Measured: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Area under the curve (AUC)）
Area under the curve (AUC)
Measured: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Terminal half-life (t½)）
Terminal half-life (t½)
Measured: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start12 Jan 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vibrant Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222969
- Sponsor's protocol ID
- VIB305-001
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation and Dose-expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of VIB305 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07222969
- Acronym / sponsor ID
- VIB305-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Vibrant Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VIB305 for Injection in Cohort 1 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 1 according to protocol |
| VIB305 for Injection in Cohort 2 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 2 according to protocol |
| VIB305 for Injection in Cohort 3 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 3 according to protocol |
| VIB305 for Injection in Cohort 4 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 4 according to protocol |
| VIB305 for Injection in Cohort 5 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 5 according to protocol |
| VIB305 for Injection in Cohort 6 | Experimental | Drug: VIB305 for InjectionVIB305 for Injection does in Cohort 6 according to protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged ≥18 years, male or female.
- Subjects with histologically or cytologically confirmed advanced solid tumors that are unresectable, who are refractory to or intolerant of or refuse all existing therapy(ies) known to provide clinical benefit for their condition.
- 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.
Key exclusion criteria (26 listed)
- Receipt of chemotherapy, biotherapy, endocrine therapy, immunotherapy, or other systemic anti-tumor therapy within 4 weeks prior to first dose of investigational drug.
- Receipt of radiotherapy within 4 weeks prior to initiation of study treatment, or history of radiation pneumonitis.
- Receipt of any other investigational drugs not yet marketed within 4 weeks prior to first dose of investigational drug.
- Receipt of major organ surgery or occurrence of significant trauma, or requirement for elective surgery during the study, within 4 weeks prior to first dose of investigational drug.
- Use of systemic glucocorticoids or other immunosuppressive agents within 14 days prior to the first dose of investigational drug or anticipated need during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIB305 for InjectionIntravenous infusion: once every week, each treatment cycle is 3 weeks. | Drug | VIB305 for Injection in Cohort 1, VIB305 for Injection in Cohort 2, VIB305 for Injection in Cohort 3, VIB305 for Injection in Cohort 4, VIB305 for Injection in Cohort 5, VIB305 for Injection in Cohort 6 |
Primary outcome
MTD and/or RP2D based on the incidence and nature of DLTs
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Incidence of dose-limiting toxicities (DLTs)
Adverse events（AE）
Time frame: From signed ICF to 30 days after the last drug administration
Include SAEs, TEAEs
9 secondary outcomes
The immunogenicity of VIB305
Time frame: Pre-dose of Cycle 1, Cycle 1 Day 15, pre-dose of Cycle 2, Cycle 2 Day 15, pre-dose of Cycle 3, Cycle 4 and following cycle(each cycle is 21 days) , 30 days after the last administration, 90 days after the last administration
Objective response rate (ORR)
Time frame: From signed ICF to 30 days after the last drug administration
Duration of response (DOR)
Time frame: From signed ICF to 30 days after the last drug administration
Disease control rate(DCR)
Time frame: From signed ICF to 30 days after the last drug administration
Progression-free survival (PFS)
Time frame: From signed ICF to 30 days after the last drug administration
The pharmacokinetics (PK) profile of VIB305（Maximum concentration (Cmax)）
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Time of Cmax (Tmax)）
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Area under the curve (AUC)）
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305（Terminal half-life (t½)）
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VIB305 for Injection in people with Advanced Solid Tumors, run by Vibrant Sciences Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (+86-020-82513080, liwenting@vibrantx.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD and/or RP2D based on the incidence and nature of DLTs (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.