Participants With Advanced Solid Tumor MalignanciesPhase 1/2NCT07136779
First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
A Phase 1/2 study testing VBC101 in people with Participants With Advanced Solid Tumor Malignancies, run by VelaVigo Bio Inc at 5 sites in United States.
Trial summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify 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
- Participants With Advanced Solid Tumor Malignancies
- What is being tested?
- VBC101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Sep 2025to 1 Jul 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
- A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
- 1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
- 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
- 4. Male or female adults (defined as ≥ 18 years of age)
- 5. ECOG performance status 0-1
Show all 11Show fewer
- 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
- 7. Life expectancy greater than 12 weeks
- 8. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
- 9. Adequate organ and bone marrow function
- 10. Participants must meet the minimum washout period requirements before the first dose of investigational drug
Who cannot join
- 1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.
- 2. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
- 3. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
- 4. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
- 5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira, 703-783-4510, aspira@nextoncology.com
- Recruiting
Start Midwest
Grand Rapids, Michigan, 49546
Nehal Lakhani, 16169545554, nehal.lakhani@startresearch.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
David S. Hong, 713-563-5844, dshong@mdanderson.org
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
David Sommerhalder, MD, +1 2105809500, dsommerhalder@nextoncology.com
- Recruiting
START Mountain Region, LLC.
West Valley City, Utah, 84119
William McKean, 801-907-4750, william.mckean@startresearch.com
About this study
Official title: PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify 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 VBC101.
Read the detailed description
Protocol Version：V1.3 Version Date：2026-04-20
- Being tested
- VBC101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBC101Drug
VBC101
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion） | Experimental | Not described Receives: Drug: VBC101 |
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 VBC101 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 VBC101
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 VBC101
Secondary outcomes (11)
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 VBC101 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 VBC101 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 VBC101 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)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Measured: From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause.
Measured: From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of VBC101: Plasma PK concentrations
Measurement of plasma concentrations of VBC101, total antibody and total unconjugated warhead
Measured: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Measured: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: 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 VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: 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 VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Measured: From date of first dose of VBC101 up until 30 days post last dose
Immunogenicity of VBC101: 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 VBC101 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 posted22 Aug 2025
- Study start23 Sep 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 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
- 310 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
- NCT07136779
- Sponsor's protocol ID
- VBC101-01-01
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 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 VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
- ClinicalTrials.gov ID
- NCT07136779
- Acronym / sponsor ID
- VBC101-01-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- VelaVigo Bio IncIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 Aug 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 is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts an accelerated titration for the first dose level, followed by BOIN design to identify 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 VBC101.
Detailed description
Protocol Version：V1.3 Version Date：2026-04-20
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: VBC101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
- 1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
- 2. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or for which no standard treatment is available
- 3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria
- 4. Male or female adults (defined as ≥ 18 years of age)
Key exclusion criteria (5 listed)
- 1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor.
- 2. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug.
- 3. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101)
- 4. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101).
- 5. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) 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 |
|---|---|---|
| VBC101VBC101 | 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 VBC101 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 VBC101
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 VBC101
Number of patients with adverse events by system organ class and preferred term
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: From date of first dose of VBC101 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 VBC101 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 VBC101 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)
Progression free Survival (PFS)
Time frame: From date of first dose of VBC101 up until date of progression or death due to any cause (approximately 2 years)
Overall Survival (OS)
Time frame: From date of first dose of VBC101 up until the date of death due to any cause (approximately 2 years)
Pharmacokinetics of VBC101: Plasma PK concentrations
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Area under the concentration time curve (AUC)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Pharmacokinetics of VBC101: Half-life
Time frame: From date of first dose of VBC101 up until 30 days post last dose
Immunogenicity of VBC101: Anti-Drug Antibodies (ADA)
Time frame: From date of first dose of VBC101 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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Participants With Advanced Solid Tumor Malignancies
RecruitingPhase 1/2
GST101 in Participants With RAS-Mutant Advanced Solid Tumors
RAS-mutant Advanced Solid Tumors
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
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.
5 sites 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 VBC101 in people with Participants With Advanced Solid Tumor Malignancies, run by VelaVigo Bio Inc at 5 sites in United States.
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 11 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 3 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 5 sites in United States. 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 Chen Li (+86 13681943496, chen.li@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: (DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days)). The study lists 3 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 3 Sep 2026.