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SIGVOTATUG VEDOTIN

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.

Table of Contents

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.[1][2][3]

The available studies include two Phase 3 trials in non-small cell lung cancer and one Phase 1 trial in advanced solid tumors.[1][2][3]

All three studies are listed as Authorised, which means they have been allowed to start.[1][2][3]

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.[1]

This study compares SIGVOTATUG VEDOTIN plus pembrolizumab with pembrolizumab alone, and it includes 745 participants.[1]

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.[1]

The second Phase 3 study, 2023-503827-25-01, is in previously treated non-small cell lung cancer and includes 635 participants.[2]

This study compares SIGVOTATUG VEDOTIN with docetaxel, which is the control treatment in this trial.[2]

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.[2]

Phase 1 study in advanced solid tumors

The Phase 1 study, NCT07227298, includes adults with advanced solid tumors and has 162 planned participants.[3]

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.[3]

Phase 1 is mainly used to learn about safety, tolerability, and dose selection before larger studies are done.[3]

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.[3]

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.[1][2]

They also measure progression-free survival (PFS), which means the length of time before the cancer gets worse.[1][2]

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.[1][2]

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.[3]

The Phase 1 study also measures confirmed objective response rate (ORR), meaning the share of participants whose tumors shrink or disappear for a time.[3]

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.[1]

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.[2]

The Phase 1 study is broader and includes people with advanced solid tumors, so it is not limited to one cancer type.[3]

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.[1][2][3]

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.[1][2][3]

Together, the trials are building evidence on whether SIGVOTATUG VEDOTIN can improve cancer control in people with difficult-to-treat disease.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT06758401 Phase 3 Locally advanced, unresectable, or metastatic non-small cell lung cancer with high PD-L1 Authorised 745
2023-503827-25-01 Phase 3 Previously treated non-small cell lung cancer Authorised 635
NCT07227298 Phase 1 Advanced solid tumors Authorised 162

FAQ

  • What is being studied in SIGVOTATUG VEDOTIN trials? The trials are checking whether SIGVOTATUG VEDOTIN can help people with cancer live longer and have slower disease growth. Some studies also test safety, tolerability, and the best dose combinations.
  • Which cancers are included in these studies? The main cancer studied is non-small cell lung cancer. One trial also includes advanced solid tumors, which means solid cancers that have spread or are hard to treat.
  • Who can take part in the trials? People with locally advanced, unresectable, or metastatic non-small cell lung cancer may join one study. Another study includes people with previously treated non-small cell lung cancer, and one includes adults with advanced solid tumors.
  • What trial phases are being done? The studies include Phase 1 and Phase 3 trials. Phase 1 focuses more on safety and dose finding, while Phase 3 compares treatment results in larger groups.
  • What results are the trials measuring? The trials measure overall survival, which means how long people live, and progression-free survival, which means how long the cancer does not get worse. They also measure response rate, side effects, and dose-limiting toxicities.

Ongoing Clinical Trials on SIGVOTATUG VEDOTIN

  • Study of Sigvotatug Vedotin and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer with High PD-L1 Levels

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark France +9

  • A study of PF-08634404 and sigvotatug vedotin in patients with advanced solid tumors

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France Germany Italy Spain

  • Study Comparing SGN-B6A and Docetaxel for Adults with Previously Treated Non-Small Cell Lung Cancer

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +7

Glossary

  • Non-small cell lung cancer (NSCLC): A common type of lung cancer. It grows and spreads differently from small cell lung cancer.
  • Locally advanced: Cancer that has grown outside its first place but has not spread far through the body.
  • Unresectable: Not able to be removed with surgery.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Advanced solid tumors: Solid cancers, such as lung or other organ cancers, that are advanced and harder to treat.
  • Phase 1: An early clinical trial phase that mainly checks safety, side effects, and dose.
  • Phase 3: A later trial phase that compares treatments in larger groups of people.
  • Overall survival (OS): How long people live after starting treatment.
  • Progression-free survival (PFS): How long a person lives without the cancer getting worse.
  • RECIST v1.1: A standard way to measure whether a tumor gets smaller, stays the same, or grows.
  • Blinded independent central review (BICR): A review of scan results by experts who do not know which treatment a person received.
  • Objective response rate (ORR): The percentage of people whose cancer gets smaller or disappears for a time.

References