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NCT05070247 · OUTCOME

Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Cycle 1 (1 cycle = 21 days)

What was measured

DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.

Analysis population: The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration.

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/kg3
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg3
Single Agent Dose Escalation: TAK-500 16 µg/kg5
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg3
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg3
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg7
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg3
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg2
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg6
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg4
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg5
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg5
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg6
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Single Agent Dose Escalation: TAK-500 8 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: TAK-500 16 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg2Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg0Not reportedNot reportedNot reportedNot reported
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg2Not reportedNot reportedNot reportedNot reported
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg0Not reportedNot reportedNot reportedNot reported
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg0Not reportedNot reportedNot reportedNot reported
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg0Not reportedNot reportedNot reportedNot reported
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
        2
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      2
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      4
    11. group Id
      OG010
      value
      5
    12. group Id
      OG011
      value
      5
    units
    Participants
description
DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
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
param Type
COUNT_OF_PARTICIPANTS
population Description
The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration.
reporting Status
POSTED
time Frame
Up to Cycle 1 (1 cycle = 21 days)
title
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice