In short
Clinical trials are investigating SGN-ALPV in people with advanced solid tumors. The study is looking at safety, tolerability, dose finding, and early signs of benefit in several cancer types, including lung, stomach, cervical, ovarian, endometrial, and germ cell tumors.
Key points
- SGN-ALPV has been studied in a Phase 1 clinical trial in people with advanced solid tumors. The trial included several cancer types, such as non-small cell lung cancer, gastric cancer, cervical cancer, ovarian cancer, endometrial cancer, and selected germ cell tumors. The main goals were to evaluate safety, tolerability, and to find the maximum tolerated dose. Researchers also looked for a recommended dose and schedule for future study. The main measurements were adverse events, laboratory abnormalities, and dose-limiting toxicities.
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.
This was a Phase 1 trial, which is the first step of testing in people and usually focuses on safety and dose finding.
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.
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.
People with pure teratomas were excluded, and the study also excluded tumors with primary sites arising from the central nervous system.
What the study measured
The main goal was to evaluate the safety and tolerability of SGN-ALPV.
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.
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.
Another goal was to find the maximum tolerated dose and a recommended dose and schedule for later parts of the study.
Study phase and design
The trial was an interventional study, which means participants received the study treatment directly as part of the research.
The study was completed and enrolled 254 people.
SGN-ALPV was given by intravenous administration, which means it was delivered through a vein.
Key trial details
- Trial ID: NCT05229900.
- Phase: Phase 1.
- Status: Completed.
- Enrollment: 254 participants.
- Main focus: Safety, tolerability, dose limits, and dose selection for future study.