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SL-172154 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Shattuck Labs, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, or 2

All subjects must have documentation of at least one tumor protein 53 (TP53) gene mutation/deletion based on local test.

Must not have

Known or active human immunodeficiency virus (HIV) infection

Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

Adults with certain types of blood cancers (AML or MDS) who meet specific criteria, such as having a TP53 gene mutation and not exceeding four prior treatments for AML or any treatment for MDS. They must be in stable condition, not pregnant, willing to use contraception, and able to provide consent. People with active infections, recent heart issues, other malignancies requiring therapy, or those on immunosuppressants can't join.

What is being tested?

The trial is testing SL-172154 alone and in combination with azacitidine or both azacitidine and venetoclax. It's an early-stage study focusing on safety and how the body processes the drug while also looking at initial signs of effectiveness against these blood cancers.

What are the potential side effects?

While specific side effects are not listed here, typical ones may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue from anemia or treatment effects on normal cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My cancer has a TP53 gene mutation.

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My diagnosis of MDS is confirmed and I have less than 20% blasts in my bone marrow.

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I have AML or MDS and have had 1-4 treatments after my disease came back or didn't respond.

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My AML diagnosis is confirmed and does not include acute promyelocytic leukemia.

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I am 18 years old or older.

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My AML has returned or didn't respond after 1-4 treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV.

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I do not have any current bleeding issues or a history of serious blood clotting problems.

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I have been treated with a SIRPα-targeting antibody before.

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I have been tested positive for hepatitis B or C.

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I have severe heart failure.

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I have received CAR-T cell therapy.

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I do not have serious heart rhythm problems that are not controlled by medication.

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I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed while in this study.

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I cannot take pills or treatments by mouth due to a condition.

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I haven't had serious stomach or bowel issues causing diarrhea in the last 6 months.

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I have had an organ transplant.

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My leukemia has spread to my brain or spinal cord.

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My blood pressure is not well-controlled.

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I have myocarditis.

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I do not have any major heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part D- To evaluate safety and anti-tumor activity of SL-172154 at 1.0 mg/kg and 3.0 mg/kg administered with azacitidine vs azacitidine monotherapy in higher-risk MDS subjects

Part D- To evaluate safety and anti-tumor activity of SL-172154 at 1.0 mg/kg vs 3.0 mg/kg administered with azacitidine in higher-risk MDS subjects

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

+1 more

Secondary study objectives

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)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: SL-172154 + Azacitidine + VenetoclaxExperimental Treatment1 Intervention

Patients will receive intravenous administration of SL-172154 and Azacitidine plus oral venetoclax.

Group II: SL-172154 + AzacitidineExperimental Treatment1 Intervention

Patients will receive intravenous administration of SL-172154 and Azacitidine.

Group III: SL-172154Experimental Treatment1 Intervention

Patients will receive intravenous administration

Group IV: Part D-Previously untreated HR-MDS 1:1:1 RandomizationExperimental Treatment1 Intervention

Previously untreated MDS patients with or without TP53 mutation will be randomized to receive the following: * 3 mg/kg SL-172154 + Azacitidine * 1 mg/kg SL-172154 + Azacitidine * Azacitidine Monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SL-172154

2020

Completed Phase 1

~40

0 / 22Eligibility criteria met