The purpose of this study is to assess the safety and tolerability of TJ011133 in
participants with solid tumors and lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03934814.
This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety,
tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD),
pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133,
an anti-CD47 antibody, in participants with advanced relapsed or refractory solid tumors
and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent
dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B
with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion
study.
Lead OrganizationI-Mab Biopharma US Limited