Participants With Advanced Solid Tumor MalignanciesPhase 1/2NCT07299747
Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors
A Phase 1/2 study testing VBC103 in people with Participants With Advanced Solid Tumor Malignancies, run by VelaVigo Bio Inc at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Participants With Advanced Solid Tumor Malignancies
- What is being tested?
- VBC103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2025to 1 Dec 2028
- 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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201209
Jian Zhang
About this study
Official title: A Phase I/IIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors
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.
Read the detailed description
Protocol Version：V1.1 Version Date：2025-12-12
- Being tested
- VBC103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBC103Drug
VBC103
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） | Experimental | Not described Receives: Drug: VBC103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)
Incidence of Serious Adverse Events
Number of patients with serious adverse events by system organ class and preferred term
Measured: From time of Informed Consent to 30 days post last dose of VBC103
Secondary outcomes (7)
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)
Measured: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
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
Measured: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
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
Measured: 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)
Pharmacokinetics of VBC103: Plasma PK concentrations
Measurement of plasma concentrations of VBC103, total antibody and total unconjugated warhead
Measured: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Measured: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Measured: From date of first dose of VBC103 up until 30 days post last dose
Immunogenicity of VBC103: Anti-Drug Antibodies (ADA)
Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment
Measured: From date of first dose of VBC103 up until 30 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start4 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants With Advanced Solid Tumor MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VelaVigo Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299747
- Sponsor's protocol ID
- VBC103-01-01
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07299747
- Acronym / sponsor ID
- VBC103-01-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- VelaVigo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 23 Dec 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） | Experimental | Drug: VBC103 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| VBC103VBC103 | Drug | Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） |
Primary outcome
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: (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
Time frame: 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
7 secondary outcomes
Objective Response Rate (ORR)
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)
Duration of Response (DOR)
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)
Disease Control Rate (DCR) at 12 weeks
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)
Pharmacokinetics of VBC103: Plasma PK concentrations
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose of VBC103 up until 30 days post last dose
Immunogenicity of VBC103: Anti-Drug Antibodies (ADA)
Time frame: From date of first dose of VBC103 up until 30 days post last dose
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 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VBC103 in people with Participants With Advanced Solid Tumor Malignancies, run by VelaVigo Bio Inc at 1 site in China.
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 8 inclusion and 4 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 Jian Zhang (021-64175590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLT) as defined in the protocol (time frame: (DLT)From time of first dose of VBC103 to end of DLT period (approximately 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 22 Apr 2026.