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TAK-500-1001
Recruiting

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

Clinicaltrials.gov
#NCT05070247
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About this clinical trial

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: - to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. - to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

US
Interventional Phase 1/Phase 2 clinical trial.

At a glance

What medical conditions are being studied?

Hepatocellular Cancer
Pancreatic Cancer
Mesothelioma
Breast Cancer
Gastric Cancer
Esophageal Cancer
Nasopharyngeal Cancer
Kidney Cancer
Squamous Cell Cancer of Head and Neck (SCCHN)
Non-small Cell Lung Cancer (NSCLC), Non-squamous

What is the clinical trial testing?

TAK-500, Pembrolizumab

How many participants are being enrolled?

313

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Apr 2022 - Aug 2026

How long is participation in the clinical trial?

Each participant will be in this study for a maximum of about 12 months.

Key requirements

Sexes

All

Age

18+ years

Healthy volunteers?

No

Entry criteria

Both men and women can take part.
Must be adults 18 years or older.
Must be diagnosed with select locally advanced or metastatic solid tumors.
Additional entry criteria will be discussed with the study doctor.

For researchers

About

Access to clinical trial data is important for the advancement of medical science. Takeda is committed to responsible sharing of information related to approved medicines with qualified researchers. As an ethical steward of patient data, Takeda shares the data in a way that protects privacy. Takeda primarily shares patient-level data via Vivli. Vivli is a global data-sharing and analytics platform that provides researchers access to clinical studies across numerous disease areas in an anonymized, protected format.

Locations

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