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Recruiting NCT07299747

Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors

Phase I / Phase II Interventional Participants With Advanced Solid Tumor Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VBC103.
Who it may be relevant to
Registry conditions: Participants With Advanced Solid Tumor Malignancies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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

Interventions

  • Drug VBC103
    VBC103

Primary outcome measures

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Time frame: (DLT)From time of first dose of VBC103 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 VBC103]
Secondary outcome measures (7)
  • Objective Response Rate (ORR) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: From date of first dose of VBC103 up until 30 days post last dose]
  • Immunogenicity of VBC103: Anti-Drug Antibodies (ADA) [Time frame: From date of first dose of VBC103 up until 30 days post last dose]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07299747 · VBC103-01-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗