NCT06292208

A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors

Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced/Metastatic Solid Tumor or Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT). Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D). Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor. Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma. Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.

Conditions

• MTD

Interventions

Type	Name	Description
BIOLOGICAL	IBD0333	This is a phase I/II, open, non-randomized, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma in dose-escalation, dose-expansion, and clinical exploration phases.

Timeline

• Start date: 2024-03-09
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2024-03-05
• Last updated: 2025-01-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study