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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-500 — DRUG
  TAK-500 IV infusion.
• Pembrolizumab — DRUG
  Pembrolizumab IV infusion.
• Tocilizumab — DRUG
  Tocilizumab IV infusion.
• Dexamethasone — DRUG
  Dexamethasone IV infusion.
• Dexamethasone — DRUG
  Dexamethasone tablet.

Study Details

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.

Key Dates

Start date

Apr 14, 2022

Status verified

Jan 2026

Primary completion

Jan 6, 2025

Completion

Jan 6, 2025

Study Design

Enrollment

61 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Single Agent Dose Escalation: TAK-500 8 µg/kg
  Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI
  Participants received premedication with 8 mg/kg tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 16 µg/kg
  Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX
  Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI
  Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI
  Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
• Experimental: Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W for up to 1 year.
• Experimental: Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab
  Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year.
• Experimental: Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI
  Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
• Experimental: Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
• Experimental: Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX
  Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year.
• Experimental: Dose Expansion: TAK-500
  Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase.

Primary Outcome Measure

Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 32.8 months ]

Locations (12)

Related coverage on Hipa.ai

• Keytruda/TAK-500 Solid Tumor Study Terminated, Adverse Event Data Posted
  Pembrolizumab · Jan 22, 2026 · ClinicalTrials.gov

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