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Urothelial CarcinomaPhase 1/2NCT05234606

A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors

A Phase 1/2 study testing SBT6290 and pembrolizumab in people with Urothelial Carcinoma and Triple Negative Breast Cancer, run by Silverback Therapeutics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBT6290 and pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2022to 31 Mar 2022
Phase
Phase 1/2
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 solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer)
  • Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
  • Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria
  • ECOG Performance Status of 0 or 1
  • Adequate organ and marrow function Note: Other protocol-defined inclusion/exclusion criteria may apply.

Who cannot join

  • History of allergic reactions to certain components of study treatments
  • Untreated brain metastases
  • Currently active (or history of) autoimmune disease
  • Taking the equivalent of >10 mg / day of prednisone
  • Uncontrolled or clinically significant interstitial lung disease (ILD)
  • History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living
  • HIV infection, active hepatitis B or hepatitis C infection Note: Other protocol-defined inclusion/exclusion criteria may apply.

About this study

Official title: A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression

This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression.

Read the detailed description

This is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and preliminary antitumor activity of SBT6290 administered subcutaneously (SC) as a monotherapy and in combination with pembrolizumab in solid tumors associated with Nectin-4 expression. There are 4 parts to this study:

  • Part 1: A dose escalation of SBT6290 monotherapy
  • Part 2: Tumor-specific expansion cohorts evaluating SBT6290 monotherapy administered at the recommended phase 2 dose (RP2D) identified in Part 1
  • Part 3: A dose escalation of SBT6290 in combination with pembrolizumab
  • Part 4: An expansion cohort of SBT6290 in combination with pembrolizumab administered at the RP2D identified in Part 3 for the combination
Being tested
SBT6290, pembrolizumab
Keywords
SBT6290, breast cancer, urothelial carcinoma, non-small cell lung cancer, squamous cell carcinoma of head and neck, TLR8, Nectin-4, pembrolizumab (KEYTRUDA)
Medical subject headings
Carcinoma, Transitional Cell, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms

What participants receive

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

  • SBT6290Drug

    Escalating doses by subcutaneous (SC) injection in 21-day cycles

  • SBT6290Drug

    Dose expansion with the recommended Phase 2 dose (RP2D) by SC injection in 21-day cycles

  • pembrolizumabDrug

    Also called KEYTRUDA

    200 mg via intravenous (IV) injection in 21-day cycles

Study groups in NCT05234606
Study groupRoleWhat they receive
Part 1: SBT6290ExperimentalSBT6290 every 3 weeks
Receives: Drug: SBT6290
Part 2: SBT6290ExperimentalSBT6290 every 3 weeks
Receives: Drug: SBT6290
Part 3: SBT6290 + pembrolizumabExperimentalSBT6290 plus pembrolizumab every 3 weeks
Receives: Drug: SBT6290; Drug: pembrolizumab
Part 4: SBT6290 + pembrolizumabExperimentalSBT6290 plus pembrolizumab every 3 weeks
Receives: Drug: SBT6290; Drug: pembrolizumab

What is being measured

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

  1. Number of Participants With Dose Limiting Toxicities: Part 1 and Part 3

    Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0.

    Measured: Up to 28 days after the first dose of SBT6290

  2. Number of Participants With Treatment-emergent Adverse Events: All Parts

    Severity of treatment-emergent adverse events as assessed by the NCI CTCAE Version 5.0.

    Measured: From enrollment to 30 days after the last dose of SBT6290, up to 2 years

  3. Number of Participants With an Objective Response Rate: Part 2 and Part 4

    Complete response and partial response as assessed by RECIST Version 1.1 Criteria.

    Measured: From enrollment to confirmed response, up to 1 year

  4. Duration of Response for Participants With an Objective Response Rate: Part 2 and Part 4

    Complete response and partial response as assessed by RECIST Version 1.1 Criteria.

    Measured: From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years

Secondary outcomes (7)

  1. Number of Participants With an Objective Response Rate: Part 1 and Part 3

    Complete response and partial response as assessed by RECIST Version 1.1 Criteria.

    Measured: From enrollment to confirmed response, up to 1 year

  2. Duration of Response for Participants With an Objective Response Rate: Part 1 and Part 3

    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.

    Measured: From enrollment until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years

  3. Rate of Disease Control for Participants: All Parts

    Complete response, partial response, and stable disease as assessed by RECIST Version 1.1 Criteria.

    Measured: Up to at least 6 months after the first dose of SBT6290

  4. Progression-free Survival: Part 2

    Complete response, partial response, stable disease, and progressive disease as assessed by RECIST Version 1.1 Criteria.

    Measured: From first dose of SBT6290 until the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 3 years

  5. Estimates of Selected PK Parameters for SBT6290: All Parts

    Maximum concentration (Cmax).

    Measured: Immediately before and after SBT6290 doses up to 2 years

  6. Estimates of Selected PK Parameters for SBT6290: All Parts

    Area under the plasma concentration versus time curve (AUC).

    Measured: Immediately before and after SBT6290 doses up to 2 years

  7. Incidence of SBT6290 Antidrug Antibodies (ADA): All Parts

    Number of participants positive for ADA.

    Measured: Immediately before and after SBT6290 doses for up to 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 posted10 Feb 2022
  2. Study startMar 2022 (estimated)
  3. Primary completion31 Mar 2022
  4. Study completion31 Mar 2022

Why it stopped: Sponsor decision based on strategic re-alignment

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234606
Sponsor's protocol ID
SBT6290-101
Status last verified
Apr 2022
First submitted
13 Jan 2022
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu F, Xu K, Fan L, Li X, Liu Y, Yang F, Zhu C, Guan X. Estrogen receptor beta suppresses the androgen receptor oncogenic effects in triple-negative breast cancer. Chin Med J (Engl). 2024 Feb 5;137(3):338-349. doi: 10.1097/CM9.0000000000002930. Epub 2023 Dec 15.

    PubMed 38105538

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SBT6290 and pembrolizumab in people with Urothelial Carcinoma and Triple Negative Breast Cancer, run by Silverback Therapeutics.

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 5 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: withdrawn, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of Participants With Dose Limiting Toxicities: Part 1 and Part 3 (time frame: Up to 28 days after the first dose of SBT6290). 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 NCT05234606, which also lists 1 linked publication.

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 12 Apr 2022.

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