Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Participants With Advanced Solid Tumor Malignancies
• Intervention / Treatment: Drug: VBC103

Detailed Description

Protocol Version：V1.1 Version Date：2025-12-12

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jian Zhang; Phone Number: 021-64175590; Email: syner2000@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201209
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Jian Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）	Drug: VBC103; VBC103

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	(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	From time of Informed Consent to 30 days post last dose of VBC103

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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)	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)	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	From date of first dose of VBC103 up until 30 days post last dose

Collaborators and Investigators

• Sponsor: VelaVigo Bio Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VBC103-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No