Clinical trial · Interventional
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
NCT07299747CI-TRIAL-00109062recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Participants With Advanced Solid Tumor Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VBC103 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1 (Dose Escalation and Backfill),Phase 2(Dose optimization and Cohort Expansion)
- interventionNames
- Drug: VBC103
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol
- timeFrame
- (DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)
- description
- Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
- measure
- Incidence of Serious Adverse Events
- timeFrame
- From time of Informed Consent to 30 days post last dose of VBC103
- description
- Number of patients with serious adverse events by system organ class and preferred term
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.