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SL-279252

Phase 1

Squamous Cell Carcinoma of the Head and Neck | Small molecule | Oncology |Shattuck Labs, Inc.|Last Updated: Apr 2, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03894618SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or LymphomasPHASE1 COMPLETED 49Mar 26, 2019May 4, 2023Apr 2, 20255 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Safety Profile of SL-279252
From Day 1 to 90 days after Last Dose of SL-279252

Number of participants with treatment emergent adverse events

Maximum Tolerated Dose (MTD) of SL-279252
From Day 1 to Day 21 (Schedule 1) or Day 28 (Schedule 2)

Number of participants with dose limiting toxicities (DLTs)

Secondary Endpoints
Recommended Phase 2 Dose for SL-279252
Approximately 32 months
Overall Response Rate of SL-279252
Approximately 32 months
Immunogenicity to SL-279252
Approximately 32 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SL-279252EXPERIMENTALIntravenous administration; Two possible dosing schedules for SL-279252 may be evaluated
Interventions
NameTypeDescription
SL-279252DRUGThe investigational product (IP), SL-279252, is a first-in-class agonist redirected checkpoint (ARC) fusion protein (FP) consisting of the extracellular domains of human programmed cell death 1 (PD- 1) and OX40L, linked by a central Fc domain (PD1-Fc-OX40L).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply. 1. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations. 2. Subject has a histologi...

Countries:United StatesBelgiumCanadaSpain
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