NCT05256381 · OUTCOME

Time to Response According to iRECIST

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors · Source last updated 2025-11-17

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Day 1 up to approximately 2 years and 2 months

Groups in this outcome

Non-small Cell Lung Cancer

Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment

Colorectal Cancer

Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic

Cutaneous Squamous Cell Carcinoma

Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible

Hepatocellular Carcinoma

Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)

Metastatic Castration-resistant Prostate Cancer

Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent

Ovarian Cancer

Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months

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

Analysis denominator · Participants

Group	Source count
Non-small Cell Lung Cancer	39
Colorectal Cancer	6
Cutaneous Squamous Cell Carcinoma	11
Hepatocellular Carcinoma	11
Metastatic Castration-resistant Prostate Cancer	40
Ovarian Cancer	35

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Non-small Cell Lung Cancer	NA	Not reported	NA	NA	Insufficient number of participants with events
Colorectal Cancer	14.1	Not reported	1.6	NA	Insufficient number of participants with events
Cutaneous Squamous Cell Carcinoma	NA	Not reported	1.4	NA	Insufficient number of participants with events
Hepatocellular Carcinoma	NA	Not reported	NA	NA	Insufficient number of participants with events
Metastatic Castration-resistant Prostate Cancer	NA	Not reported	NA	NA	Insufficient number of participants with events
Ovarian Cancer	NA	Not reported	6.9	NA	Insufficient number of participants with events

Complete source fields

classes

categories
measurements
comment
Insufficient number of participants with events
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Insufficient number of participants with events
group Id
OG001
lower Limit
1.6
upper Limit
NA
value
14.1
comment
Insufficient number of participants with events
group Id
OG002
lower Limit
1.4
upper Limit
NA
value
NA
comment
Insufficient number of participants with events
group Id
OG003
lower Limit
NA
upper Limit
NA
value
NA
comment
Insufficient number of participants with events
group Id
OG004
lower Limit
NA
upper Limit
NA
value
NA
comment
Insufficient number of participants with events
group Id
OG005
lower Limit
6.9
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
6
group Id
OG002
value
11
group Id
OG003
value
11
group Id
OG004
value
40
group Id
OG005
value
35
units
Participants

dispersion Type

95% Confidence Interval

groups

description
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
id
OG000
title
Non-small Cell Lung Cancer
description
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
id
OG001
title
Colorectal Cancer
description
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
id
OG002
title
Cutaneous Squamous Cell Carcinoma
description
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
id
OG003
title
Hepatocellular Carcinoma
description
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
id
OG004
title
Metastatic Castration-resistant Prostate Cancer
description
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
id
OG005
title
Ovarian Cancer

param Type

MEDIAN

reporting Status

POSTED

time Frame

Day 1 up to approximately 2 years and 2 months

title

Time to Response According to iRECIST

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice