In short
Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER in adults with previously treated PD-L1 positive non-small-cell lung cancer and in people with advanced solid tumors. These studies aim to measure safety, tolerability, antitumor activity, and overall survival. The trials include Phase 1 and Phase 3 research.
Key points
- Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER in adults with previously treated PD-L1 positive non-small-cell lung cancer and in people with advanced solid tumors. One study is Phase 3 and compares the treatment with docetaxel, while the other is Phase 1 and looks at the treatment in combination with other anticancer agents. The main goals are to measure overall survival, safety, tolerability, dose-limiting toxicities, and confirmed response rate. The lung cancer study focuses on tumors with PD-L1 at least 1%, and also looks at a subgroup with PD-L1 at least 50%. Both trials are listed as Authorised. Together, they show early and later-stage research in different cancer groups.
Trial overview
Two interventional studies are listed for HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER. Both are marked Authorised, which means they have been approved to start.
The studies look at different cancer groups and different goals. One is a later-stage trial in non-small-cell lung cancer, and the other is an early-stage trial in advanced solid tumors.
Phase 3 study in previously treated NSCLC
The first study is a Phase 3 trial in adults with previously treated PD-L1 positive non-small-cell lung cancer (NSCLC). It compares the study medicine, also called PF-08046054/SGNPDL1V, with docetaxel.
This trial includes participants whose tumors have PD-L1 expression of at least 1%, and it also looks at a subgroup with PD-L1 of at least 50%. The main question is whether the study medicine helps people live longer than docetaxel, using overall survival as the primary outcome.
The planned enrollment for this study is 680 people.
Phase 1 study in advanced solid tumors
The second study is a Phase 1 trial in people with advanced solid tumors. It studies HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST PD-L1 CONJUGATED TO MONOMETHYL AURISTATIN E VIA A VALINE-CITRULLINE LINKER together with different anticancer agents, including PF-08634404 and Sigvotatug vedotin.
Phase 1 research often starts with a smaller group to learn about safety and to find a dose that can be studied further. This trial has two parts: a safety run-in, which is an early check of how the treatment is tolerated, and a later part focused on dose optimization and dose expansion.
The planned enrollment for this study is 162 participants.
What the trials measure
The Phase 3 lung cancer study measures overall survival (OS), which means how long participants live after treatment starts.
The Phase 1 study measures several safety and activity outcomes, including adverse events (AEs), dose-limiting toxicities (DLTs), and confirmed objective response rate (ORR) by RECIST v1.1. Adverse events are any unwanted medical problems during the study, and dose-limiting toxicities are side effects that may stop a dose from being increased. Objective response rate shows how many tumors shrink or disappear on scans or exams.
The Phase 1 study also records safety details such as type, frequency, severity, timing, seriousness, and whether the event is related to the study treatment, using NCI CTCAE version 5.0.
Who the studies are for
The Phase 3 study is for adult participants with previously treated PD-L1 positive NSCLC. This means people must already have had treatment before joining the trial.
The Phase 1 study is for people with advanced solid tumors. It is designed for a broader cancer group, not just one cancer type.
Key terms explained
- Interventional study: a trial where participants receive a study treatment so researchers can measure results.
- PD-L1: a marker found on some tumors, used here to help select participants for the lung cancer study.
- NSCLC: non-small-cell lung cancer, a common type of lung cancer.
- Docetaxel: the control treatment in the Phase 3 study.
- RECIST v1.1: a standard way to measure whether tumors shrink, stay the same, or grow.
- NCI CTCAE version 5.0: a standard grading system for side effects in cancer trials.