Clinical trial · Interventional
First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies
PHASE 1/2A OPEN-LABEL CLINICAL TRIAL EVALUATING VBC101, AN EGFR AND CMET TARGETED BI-SPECIFIC ANTIBODY DRUG CONJUGATE, IN PARTICIPANTS WITH ADVANCED SOLID TUMOR MALIGNANCIES
NCT07136779CI-TRIAL-00125672recruitingPhase 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 an accelerated titration for the first dose level, followed by 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 VBC101.
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 |
|---|---|---|---|
| VBC101 | 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: VBC101
Primary outcomes (3)
- measure
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol
- timeFrame
- (DLT)From time of first dose of VBC101 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 VBC101
- 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 for which no standard treatment is available * 3\. At least one measurable lesion as assessed by the investigator according to RECIST v1.1criteria * 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 * 10\. Participants must meet the minimum washout period requirements before the first dose of investigational drug Exclusion Criteria: 1\. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment, except for alopecia, neuropathy, or skin pigmentation changes. Participants with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the study investigator and the Sponsor's Medical Monitor. * 2\. Known or suspected brain metastases, or spinal cord compression, unless the condition has been treated, asymptomatic, and has been stable without requiring escalating doses of corticosteroids (equivalent to ≤10 mg/day prednisone) or anti-convulsant medications for at least four weeks prior for the first dose of investigational drug. * 3\. Prior treatment with an ADC targeting EGFR and/or cMet (including VBC101) * 4\. Prior treatment with any ADC carrying a TOP1i payload (including prior VBC101). * 5\. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.