HER2-positive Breast CancerPhase 1/2NCT05091528
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
A Phase 1/2 study testing SBT6050, trastuzumab deruxtecan and tucatinib in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by Silverback Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer
- What is being tested?
- SBT6050, trastuzumab deruxtecan and tucatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 7 Jul 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Breast cancer and colorectal cancer (CRC): archival biopsy tissue obtained after the last HER2-directed therapy (excluding trastuzumab and pertuzumab), or a fresh biopsy
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers
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.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Being tested
- SBT6050, trastuzumab deruxtecan, tucatinib, trastuzumab, capecitabine
- Keywords
- SBT6050, HER2, breast cancer, gastric cancer, colorectal cancer, non-small cell lung cancer, TLR8, trastuzumab deruxtecan, tucatinib, trastuzumab, capecitabine
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBT6050Drug
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
trastuzumab deruxtecanDrug
Also called ENHERTU
5.4 mg/kg by intravenous (IV) infusion in 21-day cycles
tucatinibDrug
Also called TUKYSA
300 mg by mouth (PO) twice daily (BID)
trastuzumabDrug
Also called HERCEPTIN
8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
capecitabineDrug
Also called XELODA
1000 mg/m2 PO BID for 14 days of each 21-day cycle
trastuzumab deruxtecanDrug
Also called ENHERTU
6.4 mg/kg by IV infusion in 21-day cycles
| Study group | Role | What they receive |
|---|---|---|
| SBT6050 + T-DXd (5.4 mg/kg) | Experimental | SBT6050 plus trastuzumab deruxtecan Receives: Drug: SBT6050; Drug: trastuzumab deruxtecan |
| SBT6050 + T-DXd (6.4 mg/kg) | Experimental | SBT6050 plus trastuzumab deruxtecan Receives: Drug: SBT6050; Drug: trastuzumab deruxtecan |
| SBT6050 + Tucatinib + Trastuzumab + Capecitabine | Experimental | SBT6050 plus tucatinib, trastuzumab, and capecitabine Receives: Drug: SBT6050; Drug: tucatinib; Drug: trastuzumab; Drug: capecitabine |
| SBT6050 + Tucatinib + Trastuzumab | Experimental | SBT6050 plus tucatinib and trastuzumab Receives: Drug: SBT6050; Drug: tucatinib; Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Dose Limiting Toxicities
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.
Measured: 21 days
Number of Participants With Treatment-emergent Adverse Events
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.
Measured: 18 weeks
Number of Participants With Laboratory Abnormalities
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.
Measured: 18 weeks
Number of Participants With an Objective Response Rate
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.
Measured: 0 weeks
Secondary outcomes (4)
Number of Participants With Treatment-emergent Adverse Events
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.
Measured: 0 weeks
Number of Participants With an Objective Response Rate
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.
Measured: 18 weeks
Duration of Response for Participants With an Objective Response Rate
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.
Measured: 0 weeks
Proportion of Participants With Clinical Benefit Rate
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.
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start8 Feb 2022
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Why it stopped: Sponsor decision based on strategic re-alignment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silverback Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi Hunder, MD, Study director, Silverback Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091528
- Sponsor's protocol ID
- SBT6050-201
- Status last verified
- Jul 2022
- First submitted
- 12 Oct 2021
- Last updated
- 18 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers
- ClinicalTrials.gov ID
- NCT05091528
- Acronym / sponsor ID
- SBT6050-201
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Keywords
- SBT6050, HER2, breast cancer, gastric cancer, colorectal cancer, non-small cell lung cancer, TLR8, trastuzumab deruxtecan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on strategic re-alignment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Silverback TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 18 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SBT6050 + T-DXd (5.4 mg/kg) | Experimental | Drug: SBT6050, Drug: trastuzumab deruxtecanSBT6050 plus trastuzumab deruxtecan |
| SBT6050 + T-DXd (6.4 mg/kg) | Experimental | Drug: SBT6050, Drug: trastuzumab deruxtecanSBT6050 plus trastuzumab deruxtecan |
| SBT6050 + Tucatinib + Trastuzumab + Capecitabine | Experimental | Drug: SBT6050, Drug: tucatinib, Drug: trastuzumab, Drug: capecitabineSBT6050 plus tucatinib, trastuzumab, and capecitabine |
| SBT6050 + Tucatinib + Trastuzumab | Experimental | Drug: SBT6050, Drug: tucatinib, Drug: trastuzumabSBT6050 plus tucatinib and trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- ECOG Performance Status of 0 or 1
- Adequate hematologic, hepatic, renal, and cardiac function
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBT6050Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles | Drug | SBT6050 + T-DXd (5.4 mg/kg), SBT6050 + T-DXd (6.4 mg/kg), SBT6050 + Tucatinib + Trastuzumab, SBT6050 + Tucatinib + Trastuzumab + Capecitabine |
| trastuzumab deruxtecanAlso: ENHERTU5.4 mg/kg by intravenous (IV) infusion in 21-day cycles | Drug | SBT6050 + T-DXd (5.4 mg/kg) |
| tucatinibAlso: TUKYSA300 mg by mouth (PO) twice daily (BID) | Drug | SBT6050 + Tucatinib + Trastuzumab, SBT6050 + Tucatinib + Trastuzumab + Capecitabine |
| trastuzumabAlso: HERCEPTIN8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles | Drug | SBT6050 + Tucatinib + Trastuzumab, SBT6050 + Tucatinib + Trastuzumab + Capecitabine |
| capecitabineAlso: XELODA1000 mg/m2 PO BID for 14 days of each 21-day cycle | Drug | SBT6050 + Tucatinib + Trastuzumab + Capecitabine |
| trastuzumab deruxtecanAlso: ENHERTU6.4 mg/kg by IV infusion in 21-day cycles | Drug | SBT6050 + T-DXd (6.4 mg/kg) |
Primary outcome
Proportion of Participants With Dose Limiting Toxicities
Time frame: 21 days
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.
Number of Participants With Treatment-emergent Adverse Events
Time frame: 18 weeks
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.
Number of Participants With Laboratory Abnormalities
Time frame: 18 weeks
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.
Number of Participants With an Objective Response Rate
Time frame: 0 weeks
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.
4 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events
Time frame: 0 weeks
Number of Participants With an Objective Response Rate
Time frame: 18 weeks
Duration of Response for Participants With an Objective Response Rate
Time frame: 0 weeks
Proportion of Participants With Clinical Benefit Rate
Time frame: 0 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Hunder, MD study director
Silverback Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SBT6050, trastuzumab deruxtecan and tucatinib in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by Silverback Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Dose Limiting Toxicities (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.