Study on the Safety and Effects of OBT076 and Balstilimab in Patients with Recurrent or Metastatic CD205-Positive Solid Tumors
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Oberotatug ravtansine, also known by its development code OBT076, is an investigational substance being studied for the treatment of certain solid tumors. It is an antibody-drug conjugate, a type of medicine that combines an antibody with a cancer-killing drug. The substance has not received marketing authorisation and is still in clinical development. In the trial record, it is given by intravenous use at a dose of 3 mg per kilogram of body weight.[1]
Oberotatug ravtansine is designed to target cells that carry a protein called CD205 on their surface. CD205 is found on certain tumor cells, including those from gastric cancer, non-small cell lung cancer (NSCLC), endometrial cancer, and ovarian cancer. The antibody part of the drug attaches to CD205, allowing the attached cancer-killing agent to be delivered directly to the tumor cells. This targeted approach aims to reduce damage to healthy cells compared to traditional chemotherapy.[1]
The clinical trial for oberotatug ravtansine includes patients with CD205-positive recurrent and/or metastatic solid tumors. Specific tumor types mentioned in the trial record include:
The trial notes that other tumor types may be added as more data become available.[1]
Oberotatug ravtansine is given by intravenous use, meaning it is administered directly into a vein. In the trial, the dose is 3 mg per kilogram of body weight. The trial also includes a comparison drug called Ribozar (600 mg per square meter by IV infusion) and the immunotherapy balstilimab (3 mg per kilogram intravenously), which is being tested in combination with oberotatug ravtansine.[1]
One clinical trial is registered for oberotatug ravtansine. It is a Phase 1/1b study, which is the earliest stage of testing in humans, focusing primarily on safety rather than effectiveness. The trial plans to enroll 240 participants and is currently authorised.[1]
The primary goal of the trial is to assess safety and tolerability. Specifically, researchers are measuring dose-limiting toxicities (DLTs) — side effects severe enough to prevent increasing the dose — and the maximum tolerated dose (MTD), the highest dose that can be given without unacceptable side effects. These are evaluated using the NCI CTCAE criteria, a standard system for grading side effect severity.[1]
The study tests oberotatug ravtansine in two ways: as a monotherapy (given alone) and in combination with balstilimab, an immunotherapy that helps the immune system fight cancer. The trial also aims to define the recommended Phase 2 dose (RP2D), which would be used in future larger studies if the drug is found to be safe enough.[1]
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