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NCT05070247 · OUTCOME

Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors · Source last updated 2026-01-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)

Analysis population: Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.

Groups in this outcome

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.

Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.

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.

Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg

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.

Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg

Participants received premedication with dexamethasone 10 mg 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.

Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.

Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg

Participants received premedication with dexamethasone 10 mg 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.

Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.

Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg 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.

Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg

Participants received premedication with dexamethasone 10 mg 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.

Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by 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, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.

Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.

Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Single Agent Dose Escalation: TAK-500 8 µg/kg0
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg0
Single Agent Dose Escalation: TAK-500 16 µg/kg0
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg0
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg0
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg0
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg0
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg0
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg0
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg0
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg0
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg0
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg0
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      0
    12. group Id
      OG011
      value
      0
    units
    Participants
groups
  1. description
    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.
    id
    OG000
    title
    Single Agent Dose Escalation: TAK-500 8 µg/kg
  2. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.
    id
    OG001
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
  3. description
    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.
    id
    OG002
    title
    Single Agent Dose Escalation: TAK-500 16 µg/kg
  4. description
    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.
    id
    OG003
    title
    Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
  5. description
    Participants received premedication with dexamethasone 10 mg 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.
    id
    OG004
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
  6. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.
    id
    OG005
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
  7. description
    Participants received premedication with dexamethasone 10 mg 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.
    id
    OG006
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
  8. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) 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.
    id
    OG007
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
  9. description
    Participants received premedication with dexamethasone 10 mg 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.
    id
    OG008
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
  10. description
    Participants received premedication with dexamethasone 10 mg 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.
    id
    OG009
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
  11. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by 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, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    OG010
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
  12. description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
    id
    OG011
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
population Description
Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.
reporting Status
POSTED
time Frame
Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)
title
Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice