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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).

Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

→

primary · POSTED

AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

→

primary · POSTED

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.

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.

→

primary · POSTED

A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.

Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

→

primary · POSTED

AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).

Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).

→

primary · POSTED

ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.

Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id: NCT05070247
trial label: A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 14
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
source section id
NCT05070247-om-0000
source outcome index
0
endpoint
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
endpoint definition
Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
time origin
Up to approximately 32.8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0001
source section id
NCT05070247-om-0001
source outcome index
1
endpoint
Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs
endpoint definition
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
time origin
Up to approximately 32.8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0002
source section id
NCT05070247-om-0002
source outcome index
2
endpoint
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
endpoint definition
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.
time origin
Up to Cycle 1 (1 cycle = 21 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0003
source section id
NCT05070247-om-0003
source outcome index
3
endpoint
Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs)
endpoint definition
A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
time origin
Up to approximately 32.8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0004
source section id
NCT05070247-om-0004
source outcome index
4
endpoint
Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
endpoint definition
AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs).
time origin
Up to approximately 32.8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0005
source section id
NCT05070247-om-0005
source outcome index
5
endpoint
Dose Expansion: Overall Response Rate (ORR)
endpoint definition
ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
time origin
Up to approximately 32.8 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG000
arm label
Single Agent Dose Escalation: TAK-500 8 µg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG001
arm label
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG002
arm label
Single Agent Dose Escalation: TAK-500 16 µg/kg
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG003
arm label
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG004
arm label
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG005
arm label
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG006
arm label
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
regimen
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.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG007
arm label
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
regimen
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.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG008
arm label
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
regimen
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.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG009
arm label
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
regimen
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.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG010
arm label
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
outcome key
om-0000
arm key
OG011
arm label
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
regimen
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.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05070247-om-0000#groups/OG011

harms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG000
source section id
NCT05070247-ae
event group key
EG000
event group label
Single Agent Dose Escalation: TAK-500 8 µg/kg
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG001
source section id
NCT05070247-ae
event group key
EG001
event group label
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG002
source section id
NCT05070247-ae
event group key
EG002
event group label
Single Agent Dose Escalation: TAK-500 16 µg/kg
serious affected
4
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG003
source section id
NCT05070247-ae
event group key
EG003
event group label
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG004
source section id
NCT05070247-ae
event group key
EG004
event group label
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG005
source section id
NCT05070247-ae
event group key
EG005
event group label
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
serious affected
5
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG006
source section id
NCT05070247-ae
event group key
EG006
event group label
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG007
source section id
NCT05070247-ae
event group key
EG007
event group label
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG008
source section id
NCT05070247-ae
event group key
EG008
event group label
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG009
source section id
NCT05070247-ae
event group key
EG009
event group label
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
serious affected
4
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG010
source section id
NCT05070247-ae
event group key
EG010
event group label
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
serious affected
3
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT05070247
harm key
EG011
source section id
NCT05070247-ae
event group key
EG011
event group label
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
serious affected
4
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Up to approximately 32.8 months
event definition
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice