A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers

Draft scope assessment: unclear. Attached because the study's own record names HER2 and 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

Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

Participants who were enrolled and treated with at least 1 dose of SBT6050.

→

primary · POSTED

Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

Participants who were enrolled and treated with at least 1 dose of SBT6050.

→

primary · POSTED

Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.

Participants who were enrolled and treated with at least 1 dose of SBT6050.

→

primary · POSTED

Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts.

No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.

→

secondary · POSTED

Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts.

No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.

→

secondary · POSTED

Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts.

Participants who were enrolled and treated with at least 1 dose of SBT6050.

→

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-gastric-cancer-ogivri-f3a154e8
nct id: NCT05091528
trial label: A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
applicability: unclear
applicability note: Attached because the study's own record names HER2 and 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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0000
source section id
NCT05091528-om-0000
source outcome index
0
endpoint
Proportion of Participants With Dose Limiting Toxicities
endpoint definition
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
time origin
21 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were enrolled and treated with at least 1 dose of SBT6050.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0001
source section id
NCT05091528-om-0001
source outcome index
1
endpoint
Number of Participants With Treatment-emergent Adverse Events
endpoint definition
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
time origin
18 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were enrolled and treated with at least 1 dose of SBT6050.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0002
source section id
NCT05091528-om-0002
source outcome index
2
endpoint
Number of Participants With Laboratory Abnormalities
endpoint definition
Clinically significant treatment-emergent laboratory abnormalities as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose escalation cohorts.
time origin
18 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were enrolled and treated with at least 1 dose of SBT6050.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0003
source section id
NCT05091528-om-0003
source outcome index
3
endpoint
Number of Participants With an Objective Response Rate
endpoint definition
Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose expansion cohorts.
time origin
0 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0004
source section id
NCT05091528-om-0004
source outcome index
4
endpoint
Number of Participants With Treatment-emergent Adverse Events
endpoint definition
Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0. This outcome measure applies only to participants in the dose expansion cohorts.
time origin
0 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No participants were enrolled in the dose expansion cohorts; study was terminated by Sponsor.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0005
source section id
NCT05091528-om-0005
source outcome index
5
endpoint
Number of Participants With an Objective Response Rate
endpoint definition
Complete response and partial response as assessed by RECIST Version 1.1 Criteria. This outcome measure applies only to participants in the dose escalation cohorts.
time origin
18 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who were enrolled and treated with at least 1 dose of SBT6050.
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0000
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0000
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0001
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0001
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0002
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0002
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0003
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0003
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0004
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0004
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0005
arm key
OG000
arm label
SBT6050 + T-DXd (6.4 mg/kg)
regimen
SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
outcome key
om-0005
arm key
OG001
arm label
SBT6050 + Tucatinib + Trastuzumab
regimen
SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05091528-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
harm key
EG000
source section id
NCT05091528-ae
event group key
EG000
event group label
SBT6050 + T-DXd (6.4 mg/kg)
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
18 weeks
event definition
Source null
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-gastric-cancer-ogivri-f3a154e8
nct id
NCT05091528
harm key
EG001
source section id
NCT05091528-ae
event group key
EG001
event group label
SBT6050 + Tucatinib + Trastuzumab
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
18 weeks
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice