NCT05091528 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2022-08-18

This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Proportion of Participants With Dose Limiting Toxicities

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outcome · POSTED

Number of Participants With Treatment-emergent Adverse Events

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outcome · POSTED

Number of Participants With Laboratory Abnormalities

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outcome · POSTED

Number of Participants With an Objective Response Rate

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outcome · POSTED

Number of Participants With Treatment-emergent Adverse Events

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outcome · POSTED

Number of Participants With an Objective Response Rate

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outcome · POSTED

Duration of Response for Participants With an Objective Response Rate

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outcome · POSTED

Proportion of Participants With Clinical Benefit Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Advanced or metastatic HER2-expressing (IHC 2+ or 3+) or HER2-amplified solid tumors * Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria * Tumor lesion amenable for biopsy or able to submit an adequate recent archived tumor tissue for baseline testing, as follows: 1. Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy 2. Gastric cancer and non-small-cell lung cancer (NSCLC): archival biopsy tissue taken within the past 12 months and after completion of last HER2-directed therapy, or a fresh biopsy * ECOG Performance Status of 0 or 1 * Adequate hematologic, hepatic, renal, and cardiac function Exclusion Criteria: * History of allergic reactions to certain components of study treatment therapies * Untreated brain metastases * Currently active (or history of) autoimmune disease * Taking the equivalent of \>10 mg / day of prednisone * Taking a medication that moderately induces CYP2C, strongly inhibits CYP2C8, or interacts with both enzymes (CYP3A and CYP2C8) * Uncontrolled or clinically significant interstitial lung disease (ILD) / pneumonitis that requires systemic corticosteroid treatment or suspected ILD / pneumonitis * HIV infection, active hepatitis B or hepatitis C infection
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
SBT6050 plus trastuzumab deruxtecan
intervention Names
Drug: SBT6050
Drug: trastuzumab deruxtecan
label
SBT6050 + T-DXd (5.4 mg/kg)
type
EXPERIMENTAL
description
SBT6050 plus trastuzumab deruxtecan
intervention Names
Drug: SBT6050
Drug: trastuzumab deruxtecan
label
SBT6050 + T-DXd (6.4 mg/kg)
type
EXPERIMENTAL
description
SBT6050 plus tucatinib, trastuzumab, and capecitabine
intervention Names
Drug: SBT6050
Drug: tucatinib
Drug: trastuzumab
Drug: capecitabine
label
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
type
EXPERIMENTAL
description
SBT6050 plus tucatinib and trastuzumab
intervention Names
Drug: SBT6050
Drug: tucatinib
Drug: trastuzumab
label
SBT6050 + Tucatinib + Trastuzumab
type
EXPERIMENTAL

interventions

arm Group Labels
SBT6050 + T-DXd (5.4 mg/kg)
SBT6050 + T-DXd (6.4 mg/kg)
SBT6050 + Tucatinib + Trastuzumab
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
description
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
name
SBT6050
type
DRUG
arm Group Labels
SBT6050 + T-DXd (5.4 mg/kg)
description
5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
name
trastuzumab deruxtecan
other Names
ENHERTU
type
DRUG
arm Group Labels
SBT6050 + Tucatinib + Trastuzumab
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
description
300 mg by mouth (PO) twice daily (BID)
name
tucatinib
other Names
TUKYSA
type
DRUG
arm Group Labels
SBT6050 + Tucatinib + Trastuzumab
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
description
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
name
trastuzumab
other Names
HERCEPTIN
type
DRUG
arm Group Labels
SBT6050 + Tucatinib + Trastuzumab + Capecitabine
description
1000 mg/m2 PO BID for 14 days of each 21-day cycle
name
capecitabine
other Names
XELODA
type
DRUG
arm Group Labels
SBT6050 + T-DXd (6.4 mg/kg)
description
6.4 mg/kg by IV infusion in 21-day cycles
name
trastuzumab deruxtecan
other Names
ENHERTU
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Proportion of Participants With Dose Limiting Toxicities
time Frame
21 days
description
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.
measure
Number of Participants With Treatment-emergent Adverse Events
time Frame
18 weeks
description
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.
measure
Number of Participants With Laboratory Abnormalities
time Frame
18 weeks
description
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.
measure
Number of Participants With an Objective Response Rate
time Frame
0 weeks

secondary Outcomes

description
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.
measure
Number of Participants With Treatment-emergent Adverse Events
time Frame
0 weeks
description
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.
measure
Number of Participants With an Objective Response Rate
time Frame
18 weeks
description
The length of time from the participant's first complete response or partial response as assessed by RECIST Version 1.1 Criteria until disease progression or death. This outcome measure applies to all participants.
measure
Duration of Response for Participants With an Objective Response Rate
time Frame
0 weeks
description
Complete response, partial response, or durable stable disease as assessed by RECIST Version 1.1 Criteria. This outcome measure applied only to participants in the dose expansion cohorts.
measure
Proportion of Participants With Clinical Benefit Rate
time Frame
0 weeks

Full study description

brief Summary: This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
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requested nct id
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nct id
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occurrences
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end
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exact text
NCT05091528
start
0
offset unit
unicode_code_points
query cond
Small Intestine Cancer
query disease state id
ds-small-intestine-cancer
source file
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source json pointer
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source kind
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source record id
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source string basis
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice