NCT05070247

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

An Open-label, Dose Escalation and Expansion, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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.

Conditions

• Pancreatic Cancer
• Hepatocellular 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

Interventions

Type	Name	Description
DRUG	TAK-500	TAK-500 IV infusion.
DRUG	Pembrolizumab	Pembrolizumab IV infusion.
DRUG	Tocilizumab	Tocilizumab IV infusion.
DRUG	Dexamethasone	Dexamethasone IV infusion.
DRUG	Dexamethasone	Dexamethasone tablet.

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-01-06
• Completion: 2025-01-06
• First posted: 2021-10-07
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study