TAK-500-1001

Terminated / Withdrawn

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

Clinicaltrials.gov

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.

What medical conditions were 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 was the clinical trial testing?

TAK-500, Pembrolizumab

How many participants were enrolled?

61

Were placebos part of the clinical trial?

No

When was the clinical trial conducted?

Apr 2022 - Jan 2025

How long was participation in the clinical trial?

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

Sexes

All

Age

18+ Years

Healthy volunteers?

No

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.

Study results

Primary outcome measures

Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs [Time Frame: Up to approximately 50 months]

Dose Escalation: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 50 months]

Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) [Time Frame: Up to approximately 50 months]

Dose Escalation: Number of Participants Reporting one or More Serious Adverse Event (SAEs) [Time Frame: Up to approximately 50 months]

Dose Escalation: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations [Time Frame: Up to approximately 50 months]

Dose Expansion: Overall Response Rate (ORR) [Time Frame: Up to approximately 50 months]

Secondary outcome measures

Dose Escalation and Dose Expansion: Cmax: Maximum Serum Concentration for TAK-500 [Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500 [Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500 [Time Frame: Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500 [Time Frame: Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: t1/2: Terminal Disposition Phase Half-life for TAK-500 [Time Frame: Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: CL: Total Clearance After Intravenous Administration for TAK-500 [Time Frame: Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500 [Time Frame: Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)]

Dose Escalation and Dose Expansion: Changes in Intratumoral Tumor Cell Infiltration [Time Frame: Up to 23 days after first administration of TAK-500]

Dose Escalation and Dose Expansion: Number of Participants With Positive Anti-drug Antibody (ADA) and Acquired Immunogenicity [Time Frame: Up to approximately 50 months]

Dose Escalation: Overall Response Rate (ORR) [Time Frame: Up to approximately 50 months]

Dose Escalation and Dose Expansion: Disease Control Rate (DCR) [Time Frame: Up to approximately 50 months]

Dose Escalation and Dose Expansion: Duration of Response (DOR) [Time Frame: Up to approximately 50 months]

Dose Escalation and Dose Expansion: Time to Response (TTR) [Time Frame: Up to approximately 50 months]

Dose Expansion: Progression Free Survival (PFS) [Time Frame: Up to approximately 50 months]

Dose Expansion: Overall Survival (OS) [Time Frame: Up to approximately 50 months]

Dose Expansion: Number of Participants With Grade 3 or Higher TEAEs [Time Frame: Up to approximately 50 months]

Dose Expansion: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 50 months]

Dose Expansion: Number of Participants With Dose Limiting Toxicities (DLTs) [Time Frame: Up to approximately 50 months]

Dose Expansion: Number of Participants Reporting one or More Serious Adverse Event (SAEs) [Time Frame: Up to approximately 50 months]

Dose Expansion: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations [Time Frame: Up to approximately 50 months]

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

About this clinical trial

At a glance