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

NCT04502888 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: SL03-OHD-102
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

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

Keywords

intratumoral injection

Outcome Measures

Primary Outcomes (2)

• Incidence of All Treatment Emergent Adverse Events

  Number of participants with treatment-emergent adverse events

  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.

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

  Number of participants with dose limiting toxicities (DLTs)

  From Day 1 to Day 29.

Secondary Outcomes (10)

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

  Approximately 18-24 months

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

  Approximately 18-24 months

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

  Approximately 18-24 months

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

  Approximately 18-24 months

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

  Approximately 18-24 months

Other Outcomes (3)

• 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)

  Approximately 18-24 months

• 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)

  Approximately 18-24 months

• To Estimate Progression-free Survival (PFS)

  Approximately 18-24 months

Study Arms (1)

SL-172154

EXPERIMENTAL

Intratumoral administration

Drug: Drug: SL-172154

Interventions

Drug: SL-172154 DRUG

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.

SL-172154

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shattuck Labs, Inc.: lead

Study Sites (6)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: Shattuck Labs

clinicaltrials@shattucklabs.com

919-864-2700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 6, 2020
• Study Start: September 17, 2020
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-01

Locations

US (6)