Condition: MTD · Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.
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.
This description comes directly from the study's public registry record.
Na Li · 18229969355 · lina@sunho-bio.com
Jinming Yu, M.D. · 13806406293 · sdyujinming@126.com
Always discuss trial participation with your own doctor first.
| Affiliated Cancer Hospital of Shandong First Medical University | Jinan, Shandong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06292208