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Pegylated Liposomal Doxorubicin+ SL-172154

Phase 3

Platinum-resistant Ovarian Cancer | Small molecule | Oncology |Shattuck Labs, Inc.|Trials Updated: Dec 23, 2025

Pegylated Liposomal Doxorubicin+ SL-172154 development status

Highest phase Phase 3 run by Janssen Research & Development, LLC (NCT01846611)
Phase scored for STTKPhase 1
Registered trials 7 across 3 sponsors since Sep 2004

Pegylated Liposomal Doxorubicin+ SL-172154 target and mechanism

Molecular targetF8
Target classExogenous Protein
ModalitySmall molecule

Also known as Doxil, PLD, Caelyx

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Pegylated Liposomal Doxorubicin+ SL-172154 clinical trials

Pegylated Liposomal Doxorubicin+ SL-172154 · 1 trial · 7 indications

Phase 1 1
NCT05483933Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian CancersPlatinum-resistant Ovarian Cancer
COMPLETED86 Analytics
PHASE1COMPLETED
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
Platinum-resistant Ovarian CancerUnlock trial analytics

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 to 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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Frequently asked questions about Pegylated Liposomal Doxorubicin+ SL-172154

What is Pegylated Liposomal Doxorubicin + SL-172154 used for?

Pegylated Liposomal Doxorubicin + SL-172154 is being studied in platinum-resistant ovarian cancer, including related platinum-resistant fallopian tube and primary peritoneal cancers. It combines pegylated liposomal doxorubicin, a chemotherapy agent, with SL-172154, an investigational immunotherapy. The regimen is given to adult women with these platinum-resistant gynecologic cancers.

What does SL-172154 target?

SL-172154 targets F8, an exogenous protein target. Pegylated liposomal doxorubicin is a liposomal formulation of the chemotherapy drug doxorubicin. The combination pairs this chemotherapy backbone with the F8-directed investigational agent in platinum-resistant ovarian cancer.

Who is developing Pegylated Liposomal Doxorubicin + SL-172154?

Shattuck Labs, Inc. (ticker STTK) is developing Pegylated Liposomal Doxorubicin + SL-172154. The company is the sponsor of the clinical program evaluating this combination in platinum-resistant ovarian cancer and related gynecologic cancers.

What phase is Pegylated Liposomal Doxorubicin + SL-172154 in?

Pegylated Liposomal Doxorubicin + SL-172154 is in Phase 1 development. It is investigational and has not been approved by the FDA. The program has completed one Phase 1b trial in platinum-resistant ovarian cancer and related conditions, with no active trials currently listed.

What clinical trials is Pegylated Liposomal Doxorubicin + SL-172154 in?

Pegylated Liposomal Doxorubicin + SL-172154 was evaluated in the Phase 1b trial NCT05483933, titled a study of SL-172154 administered with combination agents in subjects with ovarian cancers. That trial enrolled 86 participants across the United States, Canada, Spain, and the United Kingdom and is now completed.