A Phase I First-in-human Open-label Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors

Brief description of study

This is a medical study for people with advanced solid tumors who haven't benefited from or can't have standard treatment. The study has two parts: dose escalation and dose expansion. Dose escalation is when the physician utilizes a lower dose of the medicine and slowly increase it to find the best and safest dose to give to people. Dose expansion is when the physician uses the best and safest dose that they found in the dose escalation part of the study and give it to more people to see if it works well in treating the disease.

SIM0237 will be the treatment given during this study. SIM0237 is a medication that can help the body's immune system fight cancer by blocking a pathway called PD-1/PD-L1 that can suppress the immune system's ability to attack tumors. It does this by binding to a protein called PD-L1. Additionally, SIM0237 also contains a part called IL-15 which can activate the immune system and further help fight the cancer. In the dose escalation part, participants will receive SIM0237 at different doses, once a week in order to find the safest and most effective dose. In the dose expansion part, participants will receive SIM0237 at the recommended dose from the dose escalation portion. The study will also monitor the safety of the treatment and may stop enrollment in certain groups if there are safety concerns. The treatment will be given through a vein every 1-2 weeks until the treatment criteria are met.

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