In short
Clinical trials are studying SIGVOTATUG VEDOTIN in people with non-small cell lung cancer and other advanced solid tumors. These studies look at whether it can improve survival, slow cancer growth, and remain safe in different treatment settings. The trials include both first-line and previously treated patients.
Key points
- SIGVOTATUG VEDOTIN is being studied in clinical trials for non-small cell lung cancer and advanced solid tumors. Two large Phase 3 studies focus on lung cancer, including people with locally advanced, unresectable, metastatic, or previously treated disease. A Phase 1 study looks at safety, tolerability, dose finding, and early signs of activity in advanced cancers. The main outcomes include overall survival, progression-free survival, response rate, and treatment-related side effects. These trials are designed to see whether SIGVOTATUG VEDOTIN can improve cancer outcomes in different patient groups.
Trial overview
Clinical trials of SIGVOTATUG VEDOTIN are studying whether it can help people with cancer live longer, keep the cancer from growing, and do so with acceptable safety.
The available studies include two Phase 3 trials in non-small cell lung cancer and one Phase 1 trial in advanced solid tumors.
All three studies are listed as Authorised, which means they have been allowed to start.
Phase 3 studies in non-small cell lung cancer
One Phase 3 study, NCT06758401, is for people with locally advanced, unresectable, or metastatic non-small cell lung cancer with high levels of PD-L1.
This study compares SIGVOTATUG VEDOTIN plus pembrolizumab with pembrolizumab alone, and it includes 745 participants.
The study aims to show whether the combination helps people live longer and stay free from cancer growth for a longer time than pembrolizumab alone.
The second Phase 3 study, 2023-503827-25-01, is in previously treated non-small cell lung cancer and includes 635 participants.
This study compares SIGVOTATUG VEDOTIN with docetaxel, which is the control treatment in this trial.
It measures overall survival and progression-free survival in all participants and also in the IB6-high subgroup, which is a smaller group defined by the study.
Phase 1 study in advanced solid tumors
The Phase 1 study, NCT07227298, includes adults with advanced solid tumors and has 162 planned participants.
This early study looks at SIGVOTATUG VEDOTIN in combination with other anticancer agents, including PF-08634404 and another PD-L1-related antibody treatment listed in the trial record.
Phase 1 is mainly used to learn about safety, tolerability, and dose selection before larger studies are done.
The study has a safety run-in part, which is an early step to check how people tolerate the treatment, and a dose optimization and dose expansion part, which looks for the best dose and early signs that the treatment may work against the cancer.
Key endpoints being measured
The main endpoint in the Phase 3 lung cancer studies is overall survival (OS), which means how long participants live after starting treatment.
They also measure progression-free survival (PFS), which means the length of time before the cancer gets worse.
In these studies, PFS is assessed using RECIST v1.1, a standard method for judging tumor changes, and by BICR, which means the scan results are reviewed by independent experts who do not know which treatment was given.
In the Phase 1 study, the main safety endpoints include adverse events, which are unwanted medical problems during the study, and dose-limiting toxicities, which are side effects serious enough to affect how much treatment can be given.
The Phase 1 study also measures confirmed objective response rate (ORR), meaning the share of participants whose tumors shrink or disappear for a time.
Who may participate
The largest Phase 3 lung cancer study is for people with locally advanced, unresectable, or metastatic non-small cell lung cancer with high PD-L1 levels.
The second Phase 3 study is for people with previously treated non-small cell lung cancer, which means they have already received treatment before joining the trial.
The Phase 1 study is broader and includes people with advanced solid tumors, so it is not limited to one cancer type.
What the results mean for patients
These trials are important because they test SIGVOTATUG VEDOTIN in different settings: first-line treatment with pembrolizumab, later-line treatment after prior therapy, and early combination testing in advanced cancers.
The Phase 3 studies are designed to compare treatment results against standard options, while the Phase 1 study is designed to learn the safest and most useful way to move forward.
Together, the trials are building evidence on whether SIGVOTATUG VEDOTIN can improve cancer control in people with difficult-to-treat disease.