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Cutaneous Squamous Cell CarcinomaPhase 1NCT04502888

Ph1 Study of SL-172154 Administered Intratumorally in Subjects With Squamous Cell Carcinoma of the Head and Neck or Skin

A Phase 1 study testing Drug: SL-172154 in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma of Head and Neck, run by Shattuck Labs, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 1 open-label, multi-center, dose-escalation study to evaluate the safety, PK, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered by intratumoral injection in subjects with cutaneous squamous cell carcinoma (CSCC) or squamous cell carcinoma of the head and neck (SCCHN). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug: SL-172154
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
6 sitesUnited States
Study dates
17 Sep 2020to 8 Apr 2022
Phase
Phase 1
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

  • Participants are eligible to be included in the study only if all the following criteria apply:
  • Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
  • Subject must have a histologically confirmed diagnosis of an unresectable or recurrent, locally advanced or metastatic cutaneous squamous cell carcinoma or squamous cell carcinoma of the head and neck that is not amenable to curative surgery or radiotherapy.
  • Subjects must have received, been intolerant to, or ineligible for standard therapy(ies) known to provide clinical benefit for their condition.
  • Subject has measurable disease by RECIST v1.1 using radiologic assessment.
  • Subject has at least 1 tumor lesion measuring between 1-6cm that is cutaneous and/or subcutaneous and/or nodal and is clinically accessible and safe for injection by direct visualization, palpation or by ultrasound guidance. PD Cohort Subjects Only: Must have a second lesion that is non-injected and is amenable to tumor biopsy collection.
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  • Subject age is 18 years and older.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Has life expectancy of greater than 12 weeks.
  • Has adequate organ function.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of D1 of IP.
  • Male subjects of reproductive potential must use acceptable contraception.
  • Recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1.
  • Willing to consent to mandatory pre-treatment and on-treatment tumor biopsy(ies) of injected lesion (and non-injected lesion(s) for subjects enrolled in the PD cohort)

Who cannot join

  • Prior treatment with an anti-CD47 or anti-SIRPα targeting agent or a CD40 agonist.
  • Any anti-cancer therapy within the washout period prior to first dose (D1) of SL-172154.
  • Concurrent chemotherapy, immunotherapy, biologic or hormonal/hormonal suppression therapy for cancer treatment is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
  • Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of SL-172154 treatment.
  • Receipt of live attenuated vaccine within 28 days of D1 of IP.
  • Hypersensitivity to the active drug substance or to any of the excipients for the agent to be administered or subjects with known hypersensitivity to Chinese hamster ovary cell products.
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  • History of coagulopathy resulting in uncontrolled bleeding, eg, hemophilia, von Willebrand's disease.
  • Requires continuous anticoagulation therapy or antiplatelet therapy
  • Active or documented history of autoimmune disease. Exceptions include controlled Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
  • Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.).
  • Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of IP).
  • Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of D1 of IP.
  • Clinically significant or uncontrolled cardiac/thromboembolic disease.
  • Untreated central nervous system or leptomeningeal metastases.
  • Women who are breastfeeding.
  • Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
  • Another malignancy that requires active therapy and that in the opinion of the investigator and Sponsor would interfere with monitoring of radiologic assessments of response to IP.
  • Has undergone allogeneic stem cell transplantation or organ transplantation.
  • Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint, SL-172154 (SIRPα-Fc-CD40L), Administered Intratumorally in Subjects With Cutaneous Squamous Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck

This is a Phase 1 open-label, multi-center, dose-escalation study to evaluate the safety, PK, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered by intratumoral injection in subjects with cutaneous squamous cell carcinoma (CSCC) or squamous cell carcinoma of the head and neck (SCCHN).

Read the detailed description

This Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-172154 when administered as an intratumoral injection (ITI) and identify the dose and schedule i.e., recommended Phase 2 dose (RP2D) for future development. Eligible subjects must have unresectable or recurrent, locally advanced or metastatic squamous cell carcinoma of the skin or head and neck, that is not amenable to curative surgery or radiotherapy. The study design consists of four sequential dose-escalation cohorts and an optional pharmacodynamic cohort to obtain additional pharmacodynamic data at one or more dose levels that have completed evaluation for safety without exceeding the maximum tolerated dose (MTD).

Being tested
Drug: SL-172154
Keywords
intratumoral injection
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Drug: SL-172154Drug

    The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.

Study groups in NCT04502888
Study groupRoleWhat they receive
SL-172154ExperimentalIntratumoral administration
Receives: Drug: Drug: SL-172154

What is being measured

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

  1. Incidence of All Treatment Emergent Adverse Events

    Number of participants with treatment-emergent adverse events

    Measured: From Day 1 to 90 days after last injection of SL-172154, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.

  2. Maximum Tolerated Dose (MTD) of SL-172154 When Administered Intratumorally

    Number of participants with dose limiting toxicities (DLTs)

    Measured: From Day 1 to Day 29.

Secondary outcomes (10)

  1. Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered by Intratumoral Injection (ITI)

    Based on review of all data, including safety, tolerability, PK, anti-tumor activity and PD effects

    Measured: Approximately 18-24 months

  2. Objective Response Rate of SL-172154 When Administered by Intratumoral Injection (ITI)

    Number of participants with an objective response per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Objective response includes complete response (disappearance of all target lesions) and partial response (>/= 30% decrease in the sum of the longest diameter of target lesions).

    Measured: Approximately 18-24 months

  3. Immunogenicity to SL-172154 When Administered by Intratumoral Injection (ITI)

    Proportion of participants with positive anti-drug antibody titer

    Measured: Approximately 18-24 months

  4. Maximum Observed Concentration (Cmax) of SL-172154 When Administered by Intratumoral Injection (ITI)

    The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses

    Measured: Approximately 18-24 months

  5. Time at Which the Maximum Concentration is Observed (Tmax) of SL-172154 When Administered by Intratumoral Injection (ITI)

    The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses

    Measured: Approximately 18-24 months

  6. Minimum Observed Concentration (Cmin) of SL-172154 When Administered by Intratumoral Injection (ITI)

    The Cmin is the minimum observed serum concentration of SL-172154 following single and multiple doses

    Measured: Approximately 18-24 months

  7. Area Under the Serum Concentration Time Curve (AUC) of SL-172154 When Administered by Intratumoral Injection (ITI)

    The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154

    Measured: Approximately 18-24 months

  8. Terminal Elimination Half-life (t1/2) of SL-172154 When Administered by Intratumoral Injection (ITI)

    Terminal elimination half-life (t1/2) of SL-172154

    Measured: Approximately 18-24 months

  9. Clearance (CL) of SL-172154 When Administered by Intratumoral Injection (ITI)

    Clearance of Sl-172154

    Measured: Approximately 18-24 months

  10. Volume of Distribution of SL-172154 When Administered by Intratumoral Injection (ITI)

    Volume of distribtion of SL-172154

    Measured: Approximately 18-24 months

Timeline

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

  1. First posted6 Aug 2020
  2. Study start17 Sep 2020
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Why it stopped: Sponsor decision

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502888
Sponsor's protocol ID
SL03-OHD-102
Status last verified
Jan 2025
First submitted
31 Jul 2020
Last updated
24 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Drug: SL-172154 in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma of Head and Neck, run by Shattuck Labs, Inc. at 6 sites 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 14 inclusion and 19 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 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?

Yes. Results are posted in the registry (first posted 24 Feb 2025). 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?

Incidence of All Treatment Emergent Adverse Events (time frame: From Day 1 to 90 days after last injection of SL-172154, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.). The study lists 2 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 NCT04502888.

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 24 Feb 2025.

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