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Pegylated Liposomal Doxorubicin + SL-172154

Phase 1

Platinum-resistant Ovarian Cancer | Small molecule | Oncology |Shattuck Labs, Inc.|Last Updated: Dec 23, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05483933Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian CancersPHASE1 COMPLETED 86Aug 18, 2022Feb 7, 2025Dec 23, 202521 United States, Canada +2
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Study Endpoints
Primary Endpoints
Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab
From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months

Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts

Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab
From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months

Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects"

Secondary Endpoints
To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab
approximately 24 months
Immunogenicity to SL-172154
approximately 24 months
Immunogenicity to MIRV
approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)EXPERIMENTALPegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.
Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)EXPERIMENTALMirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration
Interventions
NameTypeDescription
Pegylated Liposomal Doxorubicin + SL-172154DRUGThe investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
Mirvetuximab + SL-172154DRUGThe investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations. 2. Age ≥18 years 3. \[PLD Cohort\] Subject has a histologically confirmed diagnosis of high grade epithelial ovarian cancer...

Countries:United StatesCanadaSpainUnited Kingdom
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