Clinical trial · Interventional
First-in-Human Trial of VBC106 in Participants With Advanced Solid Tumors
Phase 1/2a Open-Label Clinical Trial Evaluating VBC106, an FRα- and MSLN-Directed Bispecific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors
NCT07686068CI-TRIAL-00117355not yet recruitingPhase 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 is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts 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 VBC106.
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 |
|---|---|---|---|
| VBC106 | 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: VBC106
Primary outcomes (3)
- measure
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol
- timeFrame
- (DLT)From time of first dose of VBC106 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 VBC106
- 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: * \- 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 standard therapies are not appropriate or not safe in the opinion of the Investigator or refused by the participant. * 3\. At least one measurable lesion as assessed according to RECIST v1.1 criteria for participants with non-pleural mesothelioma or other solid tumors and modified RECIST(mRECIST) for participants with malignant pleural mesothelioma. * 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 Exclusion Criteria: 1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment. 2. Known or suspected brain metastases, or spinal cord compression. 3. 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. 4. Has a history of underlying pulmonary disorder including. 5. History of chronic, active, or hereditary corneal disease. 6. Participant history of congestive heart failure (CHF) Class II-IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.