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SL-172154 for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia+1 MoreSL-172154 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study the safety, how the body processes the drug, and preliminary efficacy of SL-172154 given alone or with azacitidine or azacitidine and venetoclax.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Approximately 24 months

Approximately 24 months
Area under the serum concentration-time curve (AUC)
Assess preliminary evidence of anti-tumor activity of SL-172154 administered alone or with Azacitidine OR Azacitidine + Venetoclax in subjects with higher-risk MDS or AML
Clearance (CL)
Serum
Terminal elimination half-life (t1/2)
Time at which maximum concentration of SL-172154 is observed (Tmax)
To evaluate immunogenicity to SL-172154 during and after treatment of SL-172154 administered alone or with Azacitidine OR Azacitidine + Venetoclax in subjects with higher-risk MDS or AML
Volume of distribution
Day 90
To evaluate the safety and tolerability of SL-172154 administered alone or with Azacitidine OR Azacitidine + Venetoclax in subjects with higher-risk MDS or AML
To select the recommended Phase 2 dose (RP2D) for SL-172154 administered with Azacitidine OR Azacitidine + Venetoclax in subjects with higher-risk MDS or AML

Trial Safety

Safety Progress

1 of 3

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1
Daunorubicin
1
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Trial Design

3 Treatment Groups

SL-172154
1 of 3
SL-172154 + Azacitidine + Venetoclax
1 of 3
SL-172154 + Azacitidine
1 of 3

Experimental Treatment

107 Total Participants · 3 Treatment Groups

Primary Treatment: SL-172154 · No Placebo Group · Phase 1

SL-172154
Drug
Experimental Group · 1 Intervention: SL-172154 · Intervention Types: Drug
SL-172154 + Azacitidine + Venetoclax
Drug
Experimental Group · 1 Intervention: SL-172154 · Intervention Types: Drug
SL-172154 + Azacitidine
Drug
Experimental Group · 1 Intervention: SL-172154 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 24 months

Who is running the clinical trial?

Shattuck Labs, Inc.Lead Sponsor
4 Previous Clinical Trials
228 Total Patients Enrolled
Shattuck LabsStudy DirectorShattuck Labs
4 Previous Clinical Trials
228 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with myelodysplastic syndrome (MDS) must be previously untreated
A subject must have documentation of at least one TP53 gene mutation/deletion based on local test.
Subjects with de novo AML or secondary AML with TP53 gene mutation or deletion and who are unlikely to benefit from standard intensive induction therapy or refuse intensive induction therapy at time of enrollment are eligible
You have intermediate, high or very high risk category by Revised International Prognostic Scoring System (IPSS-R).
Subjects with relapsed/refractory disease (as defined in Inclusion criterion 5) following at least 1 prior line of therapy but no more than 4 prior lines of therapy for AML or MDS.
References

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