Advanced Solid TumorsPhase 1/2NCT07772934
VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors
A Phase 1/2 study testing VBC117 in people with Advanced Solid Tumors, run by VelaVigo Bio Inc at 12 sites in 2 countries.
Trial summary
Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(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?
- VBC117
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 24 Aug 2026to 28 May 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.
- Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- Adequate organ and bone marrow function.
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 EGFR x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
China8 sites
Hunan Cancer Hospital
Changsha, Hunan, 410013
Zhenyang Liu, +86 18673181133, liuzhenyang@hnca.org.cn
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Hua Wang, +86 13667098735, dcWanghua@126.com
Jian Li, +86 13979107989, efyjgb@126.com
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Ye Guo, +86 13501678472, pattrickguo@gmail.com
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, +86 13761222111, lijin@csco.org.cn
Liaoning Cancer Hospital & Institute
Shengyang, Liaoning, 110042
Jinghui Bai, +86 18900917098, 18900917098@163.com
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Yusheng Wang, +86 13834646436, wangyusheng1972@163.com
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310009
Shanshan Weng, +86 13558118823, Nicolweng1986010@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Shuiling Jin, +86 13838008938, 13838008938@163.com
Australia4 sites
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Vinod Ganju, +61 03 9113 1301, vg@paso.com.au
Macquarie University
Randwick, New South Wales, 2031
Andrew Parsonson, +61 2 9812 3538, andrew.parsonson@mqhealth.org.au
Scientia Clinical Research
Randwick, New South Wales, 2031
Charlotte Lemech, +61 2 9382 5807, charlotte.lemech@scientiaclinicalresearch.com.au
Cancer Care Wollongong
Wollongong, New South Wales, 2500
Udit Nindra, +61 0437 000 874, udit.nindra@health.nsw.gov.au
About this study
Official title: Phase 1/2a Open-label Clinical Trial Evaluating VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.
- Conditions
- Advanced Solid Tumors
- Being tested
- VBC117
- Keywords
- Advanced Solid Tumors, VBC117, Phase 1, Phase 2a, Dose Escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBC117Drug
VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).
| Study group | Role | What they receive |
|---|---|---|
| VBC117 Dose Level 1 | Experimental | Phase 1 dose escalation and backfill: VBC117 at Dose Level 1 Receives: Drug: VBC117 |
| VBC117 Dose Level 2 | Experimental | Phase 1 dose escalation and backfill: VBC117 at Dose Level 2 Receives: Drug: VBC117 |
| VBC117 Dose Level 3 | Experimental | Phase 1 dose escalation and backfill: VBC117 at Dose Level 3 Receives: Drug: VBC117 |
| VBC117 Dose Level 4 | Experimental | Phase 1 dose escalation and backfill: VBC117 at Dose Level 4 Receives: Drug: VBC117 |
| VBC117 Dose Level 5 | Experimental | Phase 1 dose escalation and backfill: VBC117 at Dose Level 5 Receives: Drug: VBC117 |
| VBC117 Dose Level RP2D | Experimental | Phase 2a expansion cohort: VBC117 at RP2D across tumor-specific cohorts Receives: Drug: VBC117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Number of patients with Adverse Events（AEs）by system organ class and preferred term
Measured: From time of Informed Consent to 30 days post last dose of VBC117
Incidence of DLTs
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Measured: From time of first dose of VBC117 to end of DLT period (approximately 21 days)
Incidence of SAEs
Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term
Measured: From time of Informed Consent to 30 days post last dose of VBC117
Incidence of TEAE leading to dose modification or discontinuation
Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term
Measured: From time of Informed Consent to 30 days post last dose of VBC117
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
Measured: From first dose of VBC117 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 posted19 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion27 Feb 2029 (estimated)
- Study completion28 May 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
- Randomised
- Intervention model
- Sequential
- Model description
- This study consists of two parts: Phase 1, which employs a sequential BOIN dose-escalation design to evaluate safety and determine the RP2D, and Phase 2a, a parallel-group expansion cohort to assess preliminary anti-tumor activity at the RP2D.
- Masking
- None (open label)
- Enrolment
- 260 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
- NCT07772934
- Sponsor's protocol ID
- VBC117-01-01
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 22 Sep 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 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 VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07772934
- Acronym / sponsor ID
- VBC117-01-01
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, VBC117, Phase 1, Phase 2a, Dose Escalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- VelaVigo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 27 Feb 2029 (estimated)
- Study completion
- 28 May 2029 (estimated)
- First posted
- 19 Aug 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.
Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This study consists of two parts: Phase 1, which employs a sequential BOIN dose-escalation design to evaluate safety and determine the RP2D, and Phase 2a, a parallel-group expansion cohort to assess preliminary anti-tumor activity at the RP2D.
| Arm | Type | Receives |
|---|---|---|
| VBC117 Dose Level 1 | Experimental | Drug: VBC117Phase 1 dose escalation and backfill: VBC117 at Dose Level 1 |
| VBC117 Dose Level 2 | Experimental | Drug: VBC117Phase 1 dose escalation and backfill: VBC117 at Dose Level 2 |
| VBC117 Dose Level 3 | Experimental | Drug: VBC117Phase 1 dose escalation and backfill: VBC117 at Dose Level 3 |
| VBC117 Dose Level 4 | Experimental | Drug: VBC117Phase 1 dose escalation and backfill: VBC117 at Dose Level 4 |
| VBC117 Dose Level 5 | Experimental | Drug: VBC117Phase 1 dose escalation and backfill: VBC117 at Dose Level 5 |
| VBC117 Dose Level RP2D | Experimental | Drug: VBC117Phase 2a expansion cohort: VBC117 at 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 (8 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 EGFR x CDH17 bispecific ADC.
- Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.
- Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
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 |
|---|---|---|
| VBC117VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC). | Drug | VBC117 Dose Level 1, VBC117 Dose Level 2, VBC117 Dose Level 3, VBC117 Dose Level 4, VBC117 Dose Level 5, VBC117 Dose Level RP2D |
Primary outcome
Incidence of AEs
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with Adverse Events（AEs）by system organ class and preferred term
Incidence of DLTs
Time frame: From time of first dose of VBC117 to end of DLT period (approximately 21 days)
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Incidence of SAEs
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term
Incidence of TEAE leading to dose modification or discontinuation
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term
objective response rate (ORR)
Time frame: From first dose of VBC117 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
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 Sep 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.
Scientia Clinical Research
Randwick, Australia
12 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 VBC117 in people with Advanced Solid Tumors, run by VelaVigo Bio Inc at 12 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 8 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: opening soon, as of the sponsor's last update on 22 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: From time of Informed Consent to 30 days post last dose of VBC117). The study lists 5 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 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.