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HER2 Positive Solid TumorsPhase 1NCT04460456

A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

A Phase 1 study testing SBT6050, pembrolizumab and Cemiplimab in people with HER2 Positive Solid Tumors, run by Silverback Therapeutics at 12 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2 Positive Solid Tumors
What is being tested?
SBT6050, pembrolizumab and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
12 sitesin 3 countries
Study dates
27 Jul 2020to Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor
  • Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
  • Measurable disease per RECIST 1.1
  • Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic, hepatic, and cardiac function

Who cannot join

  • History of allergic reactions to certain components of SBT6050 or similar drugs
  • Untreated brain metastases
  • Active autoimmune disease or a documented history of autoimmune disease or syndrome
  • Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection
  • Additional protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Duke University

    Durham, North Carolina, 27708

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute/Tennessee Oncology

    Nashville, Tennessee, 37203

  • University of Pittsburgh Medical Center Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • The START Center for Cancer Care

    San Antonio, Texas, 78229

Other trials in United States

Australia3 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Breast Cancer Research Centre - WA

    Nedlands, Western Australia, 6009

  • Macquarie University Hospital Clinical Trials Unit

    Sydney, New South Wales, 2109

Other trials in Australia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies

Read the detailed description

This study has 5 parts. Part 1 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.

Part 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.

Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.

Being tested
SBT6050, pembrolizumab, Cemiplimab
Keywords
HER2, ERBB2, Immunotherapy, Gastric Cancer, Gastroesophageal junction, Breast Cancer, Triple Negative Breast Cancer, Stomach Cancer, Colorectal Cancer, Gastrointestinal Cancer, Non-Small Cell Lung Cancer, Monoclonal antibody, TLR8, TLR8 agonist, Antibody drug conjugate, Biliary tract cancer, Head and neck cancer, Urothelial cancer, Endometrial cancer, Pembrolizumab
Medical subject headings
Stomach Neoplasms, Breast Neoplasms, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Carcinoma, Non-Small-Cell Lung, Biliary Tract Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBT6050Drug

    Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2

  • pembrolizumabDrug

    400 mg IV

  • CemiplimabDrug

    350 mg IV

Study groups in NCT04460456
Study groupRoleWhat they receive
SBT6050 MonotherapyExperimentalEscalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.
Receives: Drug: SBT6050
SBT6050 and pembrolizumabExperimentalEscalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.
Receives: Drug: SBT6050; Drug: pembrolizumab
SBT6050 and cemiplimabExperimentalSBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.
Receives: Drug: SBT6050; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects experiencing dose limiting toxicities

    Part 1 and 3 only

    Measured: 28 days

  2. The incidence and severity of adverse events (AEs) and serious adverse events

    Parts 1, 2, 3, 4, and 5

    Measured: 2 years

  3. Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

    Parts 2, 4, and 5

    Measured: 2 years

  4. Duration of response, defined as the time from date of first response (CR or PR)

    Parts 2, 4, and 5

    Measured: 2 years

Secondary outcomes (7)

  1. Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

    Parts1 and 3 only

    Measured: 2 years

  2. Duration of response, defined as the time from date of first response (CR or PR)

    Parts 1 and 3 only

    Measured: 2 years

  3. Disease control rate, defined as CR, PR, or stable disease for at least 6 months

    Parts 1, 2, 3, 4, and 5

    Measured: 2 years

  4. Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

    Cmax: Parts 1, 2, 3, 4, and 5

    Measured: 2 years

  5. Estimates of selected pharmacokinetics (PK ) parameters for SBT6050

    AUC: Parts 1, 2, 3, 4, and 5

    Measured: 2 years

  6. Incidence of antidrug antibodies (ADA) to SBT6050

    Parts 1 and 2

    Measured: 2 years

  7. Progression free survival

    Parts 2, 4, and 5

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start27 Jul 2020
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04460456
Sponsor's protocol ID
SBT6050-101
Status last verified
Jun 2022
First submitted
29 Jun 2020
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBT6050, pembrolizumab and Cemiplimab in people with HER2 Positive Solid Tumors, run by Silverback Therapeutics at 12 sites in 3 countries.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Australia, South Korea. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The proportion of subjects experiencing dose limiting toxicities (time frame: 28 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?

On the ClinicalTrials.gov record for NCT04460456.

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 30 Jun 2022.

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