First-in-Human Trial of VBC101 in Participants With Advanced Solid Tumor Malignancies

Conditions

• Participants With Advanced Solid Tumor Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VBC101 — DRUG
  VBC101

Study Details

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.

Key Dates

Start date

Sep 23, 2025

Status verified

Apr 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2028

Study Design

Enrollment

310 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1 (Dose Escalation and Backfill)，Phase 2（Dose optimization and Cohort Expansion）

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: (DLT)From time of first dose of VBC101 to end of DLT period (approximately 21 days) ]

Central Contacts

• Chen Li
  +86 13681943496
  [email protected]

Locations (5)

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