A Phase 1, First-in-Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients with Recurring Ovarian Cancer and Other Advanced Solid Tumors

• CTIM-76 is a CLDN6 x CD3 humanized IgG1 bispecific antibody with an effector function-silenced Fc domain.

In this study, the sponsor and investigators want to learn: 

• How much of the study drug can be given with an acceptable level of side effects 

• The effects of the study drug (good and bad) 

• How much of the study drug is absorbed into the blood and how fast it is removed 

• How the study drug is acting on your body 

Part 1 of the study, called the dose escalation, will have up to 9 groups. The aim of Part 1 of the study is to find out the dose of CTIM-76 that is tolerated the best. The first group (called Cohort 1) will start with the lowest dose of CTIM-76 being studied. If that dose is found to be safe and effective, the next group (Cohort 2) will get a higher dose. This will continue for up to 8 groups. 

Part 2 of the study, called the dose expansion phase, will have 2 different dosing cohorts. Subjects will be randomized to one of two (2) doses of CTIM-76. The process of randomization is like flipping a coin to determine which dose of CTIM-76 a subject will receive. One half of the subjects will receive one (1) dose of CTIM-76 and the other half of subjects will receive a different dose of CTIM-76.  

CTIM-76 is given as intravenous (IV) injections. IV means it is given through a needle or tube (catheter) that goes into the vein. The study drug will be given once weekly as an infusion, over about 15 minutes. Each treatment cycle will last for 28 days.