Table of Contents
Trial overview
One clinical trial studied SGN-ALPV in people with advanced solid tumors, which means cancers that form a solid mass and are not limited to the blood or bone marrow.[1]
This was a Phase 1 trial, which is the first step of testing in people and usually focuses on safety and dose finding.[1]
Who was studied
The study included people with several cancer types, such as gastroesophageal junction carcinoma, non-small cell lung cancer, gastric cancer, cervical cancer, ovarian cancer, and endometrial cancer.[1]
The trial also included some germ cell tumors, including malignant ovarian germ cell tumor, malignant testicular germ cell tumor, and malignant extragonadal germ cell tumor, with some exclusions.[1]
People with pure teratomas were excluded, and the study also excluded tumors with primary sites arising from the central nervous system.[1]
What the study measured
The main goal was to evaluate the safety and tolerability of SGN-ALPV.[1]
Researchers measured the type, number, and severity of adverse events, which are health problems that happen during a study, whether or not they are caused by the treatment.[1]
The study also tracked laboratory abnormalities, which are unusual blood test or other lab results, and dose-limiting toxicities, meaning side effects that may stop a dose from being increased.[1]
Another goal was to find the maximum tolerated dose and a recommended dose and schedule for later parts of the study.[1]
Study phase and design
The trial was an interventional study, which means participants received the study treatment directly as part of the research.[1]
The study was completed and enrolled 254 people.[1]
SGN-ALPV was given by intravenous administration, which means it was delivered through a vein.[1]
