Recruiting
Phase 1
Phase 2

VBC101

Sponsor:

VelaVigo Bio Inc

Code:

NCT07136779

Conditions

Participants With Advanced Solid Tumor Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VBC101

Study Details

Brief 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. 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.

Conditions

Participants With Advanced Solid Tumor Malignancies

Study ID

NCT07136779

Start date

Sep 23, 2025

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

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.

Study Design

Enrollment

310 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）

Interventions

VBC101

VBC101

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) ]
  • Incidence of Serious Adverse Events [ Time Frame: From time of Informed Consent to 30 days post last dose of VBC101 ]
  • Incidence of Adverse Events(AEs) [ Time Frame: From time of Informed Consent to 30 days post last dose of VBC101 ]

Central Contacts and Locations

Central contacts

Chen Li

+86 13681943496chen.li@velavigo.com

Locations

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Nehal Lakhani

16169545554nehal.lakhani@startresearch.com

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David S. Hong

713-563-5844dshong@mdanderson.org

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

David Sommerhalder, MD

+1 2105809500dsommerhalder@nextoncology.com

START Mountain Region, LLC.

Recruiting

West Valley City, Utah, United States, 84119

Contacts

William McKean

801-907-4750william.mckean@startresearch.com

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Alexander Spira

703-783-4510aspira@nextoncology.com

More Information

Sponsor

VelaVigo Bio Inc

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VelaVigo Bio Inc on 2026-09-03.