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

Introduction

• Org Study ID: TAK-500-1001
• NTC ID: NCT05070247
• Lead Sponsor Name: Takeda

Overall Status

Conditions

• Clear Cell Renal Cell Carcinoma

Brief Summary

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 effects of TAK-500, when given alone and when given with pembrolizumab, on 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.

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to all standard therapy: gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
Must have at least 1 RECIST version 1.1 measurable lesion.

Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:

Absolute neutrophil count (ANC) greater than or equal to (>=) 1000/microliter (mcL), platelet count >=75,000/mcL, and hemoglobin >= 8.0 grams per deciliter (g/dL) without growth factor support for ANC or transfusion support for platelets within 14 days before the first study treatment dose.
Total bilirubin