VBC103 treatment for 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 trial will test whether VBC103 is safe, find the best dose, and see if it helps adults with advanced solid tumors who have progressed on or cannot receive standard therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 255 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VelaVigo Bio Inc (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07299747 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, multicenter, open-label, multi-dose Phase I/IIa study of the single agent VBC103 designed to define safety, tolerability, and the maximum tolerated dose or recommended Phase II dose, characterize pharmacokinetics, and obtain early signs of activity. Adult patients with unresectable advanced or metastatic solid tumors that have recurred or progressed after standard systemic therapy (or who lack or are intolerant to standard options) and who have at least one measurable lesion by RECIST v1.1 are eligible. Key baseline requirements include ECOG performance status 0–1, left ventricular ejection fraction ≥50%, life expectancy >12 weeks, and availability of tumor tissue or willingness to undergo biopsy. Major exclusions include unresolved ≥Grade 2 toxicity from prior therapy, active keratitis or corneal ulcer, and a history of interstitial lung disease.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with unresectable advanced or metastatic solid tumors that have progressed on or are intolerant to standard treatments, have measurable disease, ECOG 0–1, adequate heart function, and available tumor tissue for testing.

Not a fit: Patients with active corneal disease, a history of interstitial lung disease, unresolved significant toxicities from prior therapy, or those who still have effective standard treatment options are less likely to benefit from this early-phase trial.

Why it matters

Potential benefit: If successful, VBC103 could provide a new treatment option that slows tumor growth or extends survival for some patients with advanced solid tumors who lack standard therapies.

How similar studies have performed: This is a first-in-human program; while some early-phase oncology agents using novel mechanisms have shown promising responses, many early trials fail to demonstrate benefit in larger studies.

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).

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jian Zhang

Conditions Participants With Advanced Solid Tumor Malignancies