Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Takeda
The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will be conducted in 2 phases: Dose Escalation and Dose Expansion Phase. The study will enroll approximately 313 participants (approximately 82 in the Dose Escalation Phase and approximately 231 in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-500 along with the combination agents for the dose expansion phase. All the participants will be assigned to one of the 9 arms: * Dose Escalation: TAK-500 Single Agent (SA) * Dose Escalation: TAK-500 + Pembrolizumab * Dose Expansion: 2L NSCLC: TAK-500 recommended dose 1 for expansion (RDE 1) + Pembrolizumab * Dose Expansion: 2L NSCLC: TAK-500 recommended dose 2 for expansion (RDE 2) + Pembrolizumab * Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SA * Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SA * Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 (RDE 1) + Pembrolizumab * Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SA * Dose Expansion: 3L RCC: TAK-500 (RDE 1) + Pembrolizumab This multi-center trial will be conducted globally. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
