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NCT04406623

Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer

Completed Phase 1 Results posted Last updated 30 January 2025
What this trial tests

Phase 1 trial testing SL-172154 in Ovarian Cancer in 27 participants. Completed in 2 February 2023.

Timeline
29 June 2020
Primary endpoint
2 February 2023
2 February 2023

Quick facts

Lead sponsorShattuck Labs, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment27
Start date29 June 2020
Primary completion2 February 2023
Estimated completion2 February 2023
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Shattuck Labs, Inc. — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer or Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety Profile of SL-172154 Primary · From Day 1 to 90 days after Last Dose of SL-172154

Number of participants with treatment emergent adverse events

GroupValue95% CI
SL-172154 (0.1 mg/kg)3
SL-172154 (0.3 mg/kg)6
SL-172154 (1.0 mg/kg)4
SL-172154 (3.0 mg/kg)9
SL-172154 (10.0 mg/kg)5
Maximum Tolerated Dose (MTD) of SL-172154 Primary · From Day 1 to 90 days after Last Dose of SL-172154

Number of participants with dose limiting toxicities (DLTs)

GroupValue95% CI
SL-172154 (0.1 mg/kg)0
SL-172154 (0.3 mg/kg)0
SL-172154 (1.0 mg/kg)0
SL-172154 (3.0 mg/kg)0
SL-172154 (10.0 mg/kg)1
Recommended Phase 2 Dose (RP2D) for SL-172154 Secondary · Approximately 24 months

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

GroupValue95% CI
SL-1721543.0
Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 Secondary · Approximately 24 months

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).

GroupValue95% CI
SL-172154 (0.1 mg/kg)0
SL-172154 (0.3 mg/kg)0
SL-172154 (1.0 mg/kg)0
SL-172154 (3.0 mg/kg)0
SL-172154 (10.0 mg/kg)0
Immunogenicity to SL-172154 Secondary · Approximately 24 months

Number of participants with positive anti-drug antibody (ADA) titer, sustained ADA response (positive ADA in \>/= 2 samples without reverting to negative ADA or positive ADA in the last sample), or persistent ADA response (positive ADA in \>/= 2 samples where the first and last samples are \>/= 16 weeks apart, or positive ADA in the last sample, or only one sample but \< 16 weeks before a negative last sample).

Positive anti-drug antibody titer
GroupValue95% CI
SL-172154 (0.1 mg/kg)1
SL-172154 (0.3 mg/kg)4
SL-172154 (1.0 mg/kg)2
SL-172154 (3.0 mg/kg)3
SL-172154 (10.0 mg/kg)3
Sustained ADA response
GroupValue95% CI
SL-172154 (0.1 mg/kg)1
SL-172154 (0.3 mg/kg)3
SL-172154 (1.0 mg/kg)2
SL-172154 (3.0 mg/kg)1
SL-172154 (10.0 mg/kg)1
Persistent ADA response
GroupValue95% CI
SL-172154 (0.1 mg/kg)0
SL-172154 (0.3 mg/kg)1
SL-172154 (1.0 mg/kg)1
SL-172154 (3.0 mg/kg)1
SL-172154 (10.0 mg/kg)0
Maximum Serum Concentration (Cmax) of SL-172154 Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)117.68± 31.06
SL-172154 (0.3 mg/kg)126.33± 89.20
SL-172154 (1.0 mg/kg)545.03± 406.44
SL-172154 (3.0 mg/kg)4593.19± 90.34
SL-172154 (10.0 mg/kg)87509.31± 51.12
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)59.20± 29.92
SL-172154 (0.3 mg/kg)136.96± 93.93
SL-172154 (1.0 mg/kg)1772.77± 111.10
SL-172154 (3.0 mg/kg)3071.26± 883.11
SL-172154 (10.0 mg/kg)50484.31± 33.38
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)72.96± 55.09
SL-172154 (0.3 mg/kg)82.11± 14.84
SL-172154 (1.0 mg/kg)1240.25± 72.61
SL-172154 (3.0 mg/kg)5219.40± 151.02
SL-172154 (10.0 mg/kg)115536.25± 51.83
Minimum Serum Concentration (Cmin) of SL-172154 Secondary · Cycle 1 Day 15 and Cycle 2 Day 1 (each cycle = 28 days)

The Cmin is the minimum observed serum concentration of SL-172154 following at least one dose

Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)0± NA
SL-172154 (0.3 mg/kg)0± NA
SL-172154 (1.0 mg/kg)0± NA
SL-172154 (3.0 mg/kg)0± NA
SL-172154 (10.0 mg/kg)0± NA
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)0± NA
SL-172154 (0.3 mg/kg)0± NA
SL-172154 (1.0 mg/kg)0± NA
SL-172154 (3.0 mg/kg)0± NA
SL-172154 (10.0 mg/kg)0± NA
Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)0.50.5 – 0.5
SL-172154 (0.3 mg/kg)0.560.5 – 1.6
SL-172154 (1.0 mg/kg)0.550.5 – 2.6
SL-172154 (3.0 mg/kg)2.531.1 – 5.0
SL-172154 (10.0 mg/kg)3.432.0 – 5.0
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)0.530.5 – 0.7
SL-172154 (0.3 mg/kg)0.540.5 – 2.3
SL-172154 (1.0 mg/kg)0.570.5 – 0.6
SL-172154 (3.0 mg/kg)2.061.1 – 2.8
SL-172154 (10.0 mg/kg)3.62.0 – 3.6
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)0.50.5 – 0.5
SL-172154 (0.3 mg/kg)0.530.5 – 1.1
SL-172154 (1.0 mg/kg)0.550.5 – 1.5
SL-172154 (3.0 mg/kg)2.081.0 – 4.1
SL-172154 (10.0 mg/kg)1.971.9 – 2.0
Area Under the Serum Concentration-time Curve (AUC) Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154. AUC (0-last; from time 0 to the last quantifiable concentration) is reported for C1D1 and AUC (tau; over a dosing interval) is reported for C1D15 and C2D1.

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)143.54± 7.74
SL-172154 (1.0 mg/kg)639.40± 18.47
SL-172154 (3.0 mg/kg)7062.14± 81.59
SL-172154 (10.0 mg/kg)200095.11± 78.74
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)13030.1± 27.31
SL-172154 (10.0 mg/kg)133015.0± NA
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)6103.60± 130.09
SL-172154 (10.0 mg/kg)236849.02± 91.90
Terminal Elimination Half-life (t1/2) Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

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

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)0.50± NA
SL-172154 (1.0 mg/kg)0.37± 0.056
SL-172154 (3.0 mg/kg)0.75± 0.710
SL-172154 (10.0 mg/kg)0.86± 0.278
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)0.32± 0.132
SL-172154 (10.0 mg/kg)0.71± NA
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)0.36± 0.158
SL-172154 (10.0 mg/kg)1.30± 0.477
Clearance (CL) Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Clearance of SL-172154

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)110.64± NA
SL-172154 (1.0 mg/kg)121.22± 46.305
SL-172154 (3.0 mg/kg)35.73± 25.580
SL-172154 (10.0 mg/kg)4.13± 2.605
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)15.15± 2.650
SL-172154 (10.0 mg/kg)4.44± NA
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)44.88± 48.958
SL-172154 (10.0 mg/kg)3.17± 1.637
Volume of Distribution Secondary · Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Volume of distribution of SL-172154

Cycle 1 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)79.83± NA
SL-172154 (1.0 mg/kg)64.28± 28.528
SL-172154 (3.0 mg/kg)28.46± 17.148
SL-172154 (10.0 mg/kg)4.84± 2.982
Cycle 1 Day 15
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)7.32± 4.187
SL-172154 (10.0 mg/kg)4.53± NA
Cycle 2 Day 1
GroupValue95% CI
SL-172154 (0.1 mg/kg)NA± NA
SL-172154 (0.3 mg/kg)NA± NA
SL-172154 (1.0 mg/kg)NA± NA
SL-172154 (3.0 mg/kg)32.01± 49.282
SL-172154 (10.0 mg/kg)5.62± 3.337

Adverse events — posted to ClinicalTrials.gov

Time frame: 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 10.5 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SL-172154 (0.1 mg/kg)
Serious: 1/3 (33%)
Deaths: 2/3
SL-172154 (0.3 mg/kg)
Serious: 0/6 (0%)
Deaths: 5/6
SL-172154 (1.0 mg/kg)
Serious: 1/4 (25%)
Deaths: 3/4
SL-172154 (3.0 mg/kg)
Serious: 2/9 (22%)
Deaths: 2/9
SL-172154 (10.0 mg/kg)
Serious: 2/5 (40%)
Deaths: 1/5

Serious adverse events (5 terms)

ReactionSystemSL-172154 (0.1 mg/kg)SL-172154 (0.3 mg/kg)SL-172154 (1.0 mg/kg)SL-172154 (3.0 mg/kg)SL-172154 (10.0 mg/kg)
embolismVascular disorders
sepsisInfections and infestations
large intestine infectionInfections and infestations
lower gastrointestinal haemorrhageGastrointestinal disorders
small intestinal obstructionGastrointestinal disorders
Other adverse events (46 terms — click to expand)

ReactionSystemSL-172154 (0.1 mg/kg)SL-172154 (0.3 mg/kg)SL-172154 (1.0 mg/kg)SL-172154 (3.0 mg/kg)SL-172154 (10.0 mg/kg)
infusion related reactionInjury, poisoning and procedural complications
fatigueGeneral disorders
nauseaGastrointestinal disorders
back painMusculoskeletal and connective tissue disorders
arthralgiaMusculoskeletal and connective tissue disorders
hyperglycaemiaMetabolism and nutrition disorders
constipationGastrointestinal disorders
diarrhoeaGastrointestinal disorders
hypoalbuminaemiaMetabolism and nutrition disorders
AST increasedInvestigations
blood LDH increasedInvestigations
pruritisSkin and subcutaneous tissue disorders
hypertensionVascular disorders
anaemiaBlood and lymphatic system disorders
lymphopeniaBlood and lymphatic system disorders
sinus tachycardiaCardiac disorders
hyperbilirubinaemiaHepatobiliary disorders
abdominal distensionGastrointestinal disorders
abdominal painGastrointestinal disorders
vomitingGastrointestinal disorders
dyspepsiaGastrointestinal disorders
flatulenceGastrointestinal disorders
chillsGeneral disorders
painGeneral disorders
oedema peripheralGeneral disorders
muscle spasmsMusculoskeletal and connective tissue disorders
myalgiaMusculoskeletal and connective tissue disorders
neck painMusculoskeletal and connective tissue disorders
decreased appetiteMetabolism and nutrition disorders
dehydrationMetabolism and nutrition disorders
hyperkalaemiaMetabolism and nutrition disorders
hypomagnesaemiaMetabolism and nutrition disorders
hyponatraemiaMetabolism and nutrition disorders
hypophosphataemiaMetabolism and nutrition disorders
ALT increasedInvestigations
activated PTT prolongedInvestigations
headacheNervous system disorders
rash maculo-papularSkin and subcutaneous tissue disorders
embolismVascular disorders
thrombocytopeniaBlood and lymphatic system disorders

Most-reported serious reactions: embolism, sepsis, large intestine infection, lower gastrointestinal haemorrhage, small intestinal obstruction.

Data from ClinicalTrials.gov NCT04406623 adverse events section.

Sponsor's own description

This is a Phase 1 first in human, open label, multi-center, dose escalation study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-172154 in subjects with ovarian cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CD47-SIRPα-targeted therapeutics: status and prospects.
    Maute R, Xu J, Weissman IL. · · 2022 · cited 105× · PMID 35754851 · DOI 10.1016/j.iotech.2022.100070
  2. Dual roles and therapeutic targeting of tumor-associated macrophages in tumor microenvironments.
    Xu J, Ding L, Mei J, Hu Y, et al · · 2025 · cited 89× · PMID 40850976 · DOI 10.1038/s41392-025-02325-5
  3. CD40 stimulation as a molecular adjuvant for cancer vaccines and other immunotherapies.
    Bullock TNJ. · · 2022 · cited 89× · PMID 34282297 · DOI 10.1038/s41423-021-00734-4
  4. CD47-SIRPα blocking-based immunotherapy: Current and prospective therapeutic strategies.
    Bouwstra R, van Meerten T, Bremer E. · · 2022 · cited 82× · PMID 35908284 · DOI 10.1002/ctm2.943
  5. Tumor-Associated Macrophages in Gliomas-Basic Insights and Treatment Opportunities.
    Andersen JK, Miletic H, Hossain JA. · · 2022 · cited 60× · PMID 35267626 · DOI 10.3390/cancers14051319
  6. Targeting tumor-associated macrophages for successful immunotherapy of ovarian carcinoma.
    Truxova I, Cibula D, Spisek R, Fucikova J. · · 2023 · cited 54× · PMID 36822672 · DOI 10.1136/jitc-2022-005968
  7. Progress of CD47 immune checkpoint blockade agents in anticancer therapy: a hematotoxic perspective.
    Chen YC, Shi W, Shi JJ, Lu JJ. · · 2022 · cited 50× · PMID 34609596 · DOI 10.1007/s00432-021-03815-z
  8. Inhibition of the CD47-SIRPα axis for cancer therapy: A systematic review and meta-analysis of emerging clinical data.
    Son J, Hsieh RC, Lin HY, Krause KJ, et al · · 2022 · cited 42× · PMID 36439116 · DOI 10.3389/fimmu.2022.1027235

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Other trials of SL-172154

Trials testing the same drug.

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Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04406623.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing