CClinicalTrials.gg
Sign In
TerminatedNCT04502888Updated Feb 24, 2025Results posted

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

A Phase 1 interventional study of Drug: SL-172154 in Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma of Head and Neck, sponsored by Shattuck Labs, Inc.. Terminated at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Shattuck Labs, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Sponsor decision
Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Cutaneous Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck

Keywords

  • intratumoral injection
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 5 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shattuck Labs, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.
  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    SL-172154

    Intratumoral administration

    Drug: Drug: SL-172154

Interventions

  • DrugDrug: SL-172154

    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.

06

What researchers measure

Primary outcomes

  1. Incidence of All Treatment Emergent Adverse Events

    Number of participants with 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.

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

    Number of participants with dose limiting toxicities (DLTs)

    Time frame: From Day 1 to Day 29.

Secondary outcomes

  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

    Time frame: 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).

    Time frame: Approximately 18-24 months

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

    Proportion of participants with positive anti-drug antibody titer

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Approximately 18-24 months

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

    Clearance of Sl-172154

    Time frame: Approximately 18-24 months

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

    Volume of distribtion of SL-172154

    Time frame: Approximately 18-24 months

Other outcomes

  1. Changes From Baseline in Cell Counts to Assess Pharmacodynamic Biomarkers in Blood Prior to, On-treatment and Following SL-172154 When Administered by Intratumoral Injection (ITI)

    Circulating immune cells such as: T cells, B cells, natural killer (NK) cells, and myeloid cells and circulating chemokine and cytokine levels

    Time frame: Approximately 18-24 months

  2. Changes From Baseline in Cell Counts to Assess Pharmacodynamic Biomarkers in Tumor Tissue Prior to, On-treatment and Following SL-172154 When Administered by Intratumoral Injection (ITI)

    Presence of SL-172154 in tumor tissue, changes in T cells subsets, B cells and macrophages and assessment of SL-172154 in the tumor tissue, CD47 and CD40 expression and Programmed cell death ligand 1 (PD-L1) expression

    Time frame: Approximately 18-24 months

  3. To Estimate Progression-free Survival (PFS)

    PFS: time from first dose to progression by RECIST v1.1 or death, whichever comes first

    Time frame: Approximately 18-24 months

07

Results

Posted Feb 24, 2025

Participant flow

Participant flow — Overall Study
MilestoneSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Started32
Completed32
Not completed00

Outcome measures

PrimaryIncidence of All Treatment Emergent Adverse Events

Number of participants with 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.
Reported as:
Count of participants · Participants
Incidence of All Treatment Emergent Adverse Events
ParticipantsSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Incidence of All Treatment Emergent Adverse Events32
PrimaryMaximum Tolerated Dose (MTD) of SL-172154 When Administered Intratumorally

Number of participants with dose limiting toxicities (DLTs)

Time frame:
From Day 1 to Day 29.
Reported as:
Count of participants · Participants
Maximum Tolerated Dose (MTD) of SL-172154 When Administered Intratumorally
ParticipantsSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Maximum Tolerated Dose (MTD) of SL-172154 When Administered Intratumorally00
SecondaryEstablish 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

Time frame:
Approximately 18-24 months
Reported as:
Number · mg
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered by Intratumoral Injection (ITI)
mgSL-172154
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered by Intratumoral Injection (ITI)NA
SecondaryObjective 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).

Time frame:
Approximately 18-24 months
Reported as:
Count of participants · Participants
Objective Response Rate of SL-172154 When Administered by Intratumoral Injection (ITI)
ParticipantsSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Objective Response Rate of SL-172154 When Administered by Intratumoral Injection (ITI)00
SecondaryImmunogenicity to SL-172154 When Administered by Intratumoral Injection (ITI)

Proportion of participants with positive anti-drug antibody titer

Time frame:
Approximately 18-24 months

No measurements were reported for this outcome.

SecondaryMaximum 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

Time frame:
Approximately 18-24 months
Reported as:
Geometric mean · ng/mL
Maximum Observed Concentration (Cmax) of SL-172154 When Administered by Intratumoral Injection (ITI)
ng/mLSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Maximum Observed Concentration (Cmax) of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
SecondaryTime 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

Time frame:
Approximately 18-24 months
Reported as:
Median · hours
Time at Which the Maximum Concentration is Observed (Tmax) of SL-172154 When Administered by Intratumoral Injection (ITI)
hoursSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Time at Which the Maximum Concentration is Observed (Tmax) of SL-172154 When Administered by Intratumoral Injection (ITI)NA (NA to NA)NA (NA to NA)
SecondaryMinimum 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

Time frame:
Approximately 18-24 months
Reported as:
Geometric mean · ng/mL
Minimum Observed Concentration (Cmin) of SL-172154 When Administered by Intratumoral Injection (ITI)
ng/mLSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Minimum Observed Concentration (Cmin) of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
SecondaryArea 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

Time frame:
Approximately 18-24 months
Reported as:
Geometric mean · hours*ng/mL
Area Under the Serum Concentration Time Curve (AUC) of SL-172154 When Administered by Intratumoral Injection (ITI)
hours*ng/mLSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Area Under the Serum Concentration Time Curve (AUC) of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
SecondaryTerminal Elimination Half-life (t1/2) of SL-172154 When Administered by Intratumoral Injection (ITI)

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

Time frame:
Approximately 18-24 months
Reported as:
Mean · hours
Terminal Elimination Half-life (t1/2) of SL-172154 When Administered by Intratumoral Injection (ITI)
hoursSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Terminal Elimination Half-life (t1/2) of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
SecondaryClearance (CL) of SL-172154 When Administered by Intratumoral Injection (ITI)

Clearance of Sl-172154

Time frame:
Approximately 18-24 months
Reported as:
Mean · liters per hours
Clearance (CL) of SL-172154 When Administered by Intratumoral Injection (ITI)
liters per hoursSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Clearance (CL) of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
SecondaryVolume of Distribution of SL-172154 When Administered by Intratumoral Injection (ITI)

Volume of distribtion of SL-172154

Time frame:
Approximately 18-24 months
Reported as:
Mean · liters
Volume of Distribution of SL-172154 When Administered by Intratumoral Injection (ITI)
litersSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Volume of Distribution of SL-172154 When Administered by Intratumoral Injection (ITI)NA ± NANA ± NA
Other pre-specifiedChanges From Baseline in Cell Counts to Assess Pharmacodynamic Biomarkers in Blood Prior to, On-treatment and Following SL-172154 When Administered by Intratumoral Injection (ITI)

Circulating immune cells such as: T cells, B cells, natural killer (NK) cells, and myeloid cells and circulating chemokine and cytokine levels

Time frame:
Approximately 18-24 months

No measurements were reported for this outcome.

Other pre-specifiedChanges From Baseline in Cell Counts to Assess Pharmacodynamic Biomarkers in Tumor Tissue Prior to, On-treatment and Following SL-172154 When Administered by Intratumoral Injection (ITI)

Presence of SL-172154 in tumor tissue, changes in T cells subsets, B cells and macrophages and assessment of SL-172154 in the tumor tissue, CD47 and CD40 expression and Programmed cell death ligand 1 (PD-L1) expression

Time frame:
Approximately 18-24 months

No measurements were reported for this outcome.

Other pre-specifiedTo Estimate Progression-free Survival (PFS)

PFS: time from first dose to progression by RECIST v1.1 or death, whichever comes first

Time frame:
Approximately 18-24 months
Reported as:
Median · weeks
To Estimate Progression-free Survival (PFS)
weeksSL-172154 (0.003 mg)SL-172154 (0.01 mg)
To Estimate Progression-free Survival (PFS)NA ± NANA ± NA

Adverse events

Collected over Subjects were followed continuously for all AEs starting when a subject signed the informed consent form, throughout the course of treatment, and for 90 days after the last dose of study treatment, an average of 6 weeks. SL-172154 administration continued until disease progression or withdrawal of consent; there was no maximum treatment duration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SL-172154 (0.003 mg)0/3 (0%)0/3 (0%)3/3 (100%)
SL-172154 (0.01 mg)1/2 (50%)2/2 (100%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventSL-172154 (0.003 mg)SL-172154 (0.01 mg)
Pharyngeal haemorrhageRespiratory, thoracic and mediastinal disorders0/31/2
Acute kidney injuryRenal and urinary disorders0/31/2
HypercalcaemiaMetabolism and nutrition disorders0/31/2
HyponatraemiaMetabolism and nutrition disorders0/31/2
Most frequent other events
Showing 10 of 33
Most frequent other events
EventSL-172154 (0.003 mg)SL-172154 (0.01 mg)
AnaemiaBlood and lymphatic system disorders0/32/2
Injection site painGeneral disorders2/30/2
Oedema peripheralGeneral disorders0/31/2
COVID-19Infections and infestations0/31/2
Rash pustularInfections and infestations0/31/2
MyalgiaMusculoskeletal and connective tissue disorders0/31/2
Pain in extremityMusculoskeletal and connective tissue disorders0/31/2
NauseaGastrointestinal disorders0/31/2
FallInjury, poisoning and procedural complications0/31/2
HypercalcaemiaMetabolism and nutrition disorders0/31/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
<=18 years000
Between 18 and 65 years011
>=65 years314
Age, Continuous
Age, Continuous(years)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
Median70.0 (67 to 82)63.5 (56 to 71)70.0 (56 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
Female000
Male325
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
Hispanic or Latino000
Not Hispanic or Latino325
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White325
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
United States325
Cancer type
Cancer type(participants)SL-172154 (0.003 mg)SL-172154 (0.01 mg)Total
cutaneous squamous cell carcinoma314
squamous cell carcinoma of the head and neck011
08

Study locations

6 sites
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Study protocol · Jul 10, 2020
  • Statistical analysis plan · Mar 18, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04502888
Lead sponsor
Shattuck Labs, Inc.
Responsible party
Sponsor
First posted
Aug 6, 2020
Start date
Sep 17, 2020
Primary completion
Apr 8, 2022
Completion
Apr 8, 2022
Results posted
Feb 24, 2025
Last update
Feb 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Shattuck Labs, Inc.

Start the discussion