Advanced Solid TumorsPhase 1/2NCT07700160
First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors
A Phase 1/2 study testing VBC108 in people with Advanced Solid Tumors, run by VelaVigo Bio Inc at 12 sites in 3 countries.
Trial summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. 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?
- VBC108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 30 Jul 2026to 17 Sep 2029
- 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
- The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
- Male or female adults (defined as ≥ 18 years of age).
- ECOG performance status 0-1.
- Life expectancy greater than 12 weeks.
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- Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- Adequate organ and bone marrow function.
- Participants must meet the minimum washout period requirements before the first dose of investigational drug.
Who cannot join
- Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
- Known or suspected brain metastases, or spinal cord compression.
- Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Prior treatment with CLDN18.2 targeting CAR-T.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Dani Castillo, MD, 6262182123, dacastillo@coh.org
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Mohamad Salkeni, 7032083159, mohamad.salkeni@usoncology.com
- Recruiting
START Midwest, LLC
Grand Rapids, Michigan, 49546
Sreenivasa Chandana, 16169545554, sreenivasa.chandana@startmidwest.com
- Not yet recruiting
Laura and Issac Perlmutter Cancer Center
New York, New York, 10016
Paul Oberstein, 12123050592, paul.oberstein@nyulangone.org
- Recruiting
Next Oncology - Oncology
San Antonio, Texas, 78229
David Sommerhalder, 2105809500, dsommerhalder@nextoncology.com
China5 sites, 5 recruiting
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, 86-13911219511, doctorshenlin@sina.cn
- Not yet recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Ming Lu, 15801292978, qiminglu_mail@126.com
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jian Ruan, 86-19883156851, 12258276@qq.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, 13858195803, hzyingjieer@163.com
- Not yet recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, 86-13681973996, liu.tianshu@zs-hospital.sh.cn
Australia2 sites, 2 recruiting
- Not yet recruiting
One Clinical Research
Perth, Western Australia, 6009
Muhammad Adnan Khattak, 610452146726, adnan.khattak@health.wa.gov.au
- Recruiting
GenesisCare North Shore
St Leonards, New South Wales, 2065
Sarah Maloney, 610293555611, sarah.maloney@genesiscare.com
About this study
Official title: Phase 1/2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.
- Conditions
- Advanced Solid Tumors
- Being tested
- VBC108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBC108Drug
VBC108
| Study group | Role | What they receive |
|---|---|---|
| VBC108 Dose Level 1 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 1 Receives: Drug: VBC108 |
| VBC108 Dose Level 2 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 2 Receives: Drug: VBC108 |
| VBC108 Dose Level 3 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 3 Receives: Drug: VBC108 |
| VBC108 Dose Level 4 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 4 Receives: Drug: VBC108 |
| VBC108 Dose Level 5 | Experimental | Phase 1 dose escalation and backfill: VBC108 at Dose Level 5 Receives: Drug: VBC108 |
| VBC108 Dose Level recommended Phase 2 dose (RP2D) | Experimental | Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts Receives: Drug: VBC108 |
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: From time of first dose of VBC108 to end of DLT period ( 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 VBC108
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Measured: From time of Informed Consent to 30 days post last dose of VBC108
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 first dose of VBC108 to disease progression or death, up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start30 Jul 2026
- Primary completion7 Jul 2029 (estimated)
- Study completion17 Sep 2029 (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
- 230 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
- NCT07700160
- Sponsor's protocol ID
- VBC108-01-01
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2026
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07700160
- Acronym / sponsor ID
- VBC108-01-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- VelaVigo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 7 Jul 2029 (estimated)
- Study completion
- 17 Sep 2029 (estimated)
- First posted
- 13 Jul 2026 (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 is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VBC108 Dose Level 1 | Experimental | Drug: VBC108Phase 1 dose escalation and backfill: VBC108 at Dose Level 1 |
| VBC108 Dose Level 2 | Experimental | Drug: VBC108Phase 1 dose escalation and backfill: VBC108 at Dose Level 2 |
| VBC108 Dose Level 3 | Experimental | Drug: VBC108Phase 1 dose escalation and backfill: VBC108 at Dose Level 3 |
| VBC108 Dose Level 4 | Experimental | Drug: VBC108Phase 1 dose escalation and backfill: VBC108 at Dose Level 4 |
| VBC108 Dose Level 5 | Experimental | Drug: VBC108Phase 1 dose escalation and backfill: VBC108 at Dose Level 5 |
| VBC108 Dose Level recommended Phase 2 dose (RP2D) | Experimental | Drug: VBC108Phase 2a expansion cohort: VBC108 at recommended Phase 2 dose (RP2D) across tumor-specific cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor .
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.
- Male or female adults (defined as ≥ 18 years of age).
- ECOG performance status 0-1.
Key exclusion criteria (5 listed)
- Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
- Known or suspected brain metastases, or spinal cord compression.
- Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Prior treatment with CLDN18.2 targeting CAR-T.
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 |
|---|---|---|
| VBC108VBC108 | Drug | VBC108 Dose Level 1, VBC108 Dose Level 2, VBC108 Dose Level 3, VBC108 Dose Level 4, VBC108 Dose Level 5, VBC108 Dose Level recommended Phase 2 dose (RP2D) |
Primary outcome
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: From time of first dose of VBC108 to end of DLT period ( 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 VBC108
Number of patients with serious adverse events by system organ class and preferred term
Incidence of Adverse Events (AEs)
Time frame: From time of Informed Consent to 30 days post last dose of VBC108
Number of patients with adverse events by system organ class and preferred term
Objective Response Rate (ORR)
Time frame: From first dose of VBC108 to disease progression or death, up to approximately 2 years
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)
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 1 Sep 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.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VBC108 in people with Advanced Solid Tumors, run by VelaVigo Bio Inc at 12 sites in 3 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 5 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, China, Australia. 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 Jun Yan (15800359085, jun.yan@VelaVigo.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: From time of first dose of VBC108 to end of DLT period ( 21 days)). The study lists 4 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 1 Sep 2026.