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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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
Find a Location
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any live vaccines in the last 30 days, except for the COVID-19 vaccine.I haven't taken steroids or immunosuppressants in the last 14 days.I have HIV.I do not have any current bleeding issues or a history of serious blood clotting problems.I do not have an active, uncontrolled infection or it is controlled with medication.I can take care of myself and perform daily activities.I have been treated with a SIRPα-targeting antibody before.I haven't used drugs other than hydroxyurea to manage my blood cell counts in the last 14 days.I have been tested positive for hepatitis B or C.I have severe heart failure.I have AML or MDS and my treatment has failed or the disease came back.I haven't taken CD47 or CD40 drugs in the last 28 days.I have received CAR-T cell therapy.My cancer has a TP53 gene mutation.My diagnosis of MDS is confirmed and I have less than 20% blasts in my bone marrow.I do not have serious heart rhythm problems that are not controlled by medication.I have AML or MDS and have had 1-4 treatments after my disease came back or didn't respond.I have AML with a TP53 mutation and haven't had intensive therapy.I do not have another cancer that needs treatment which would affect this study's monitoring.I am not pregnant, breastfeeding, nor planning to become pregnant or breastfeed while in this study.I have not taken strong or moderate CYP3A inducers in the last 7 days.I cannot take pills or treatments by mouth due to a condition.I haven't had serious stomach or bowel issues causing diarrhea in the last 6 months.I have not had unstable chest pain in the last 6 months.I have not had a heart attack in the last 6 months.My AML diagnosis is confirmed and does not include acute promyelocytic leukemia.I have a chronic condition that might affect my study participation.I have been diagnosed with MDS.I have recovered from previous cancer treatments to my normal health or have only mild side effects.I am a male and will use birth control during and after treatment if my partner can have children.I haven't taken any experimental AML or MDS treatments recently.I have had an organ transplant.My leukemia has spread to my brain or spinal cord.I have taken a pregnancy test within the last 72 hours and it was negative.My blood pressure is not well-controlled.I have myocarditis.I have not had major surgery in the last 14 days.I have MDS and haven't been treated for it, except possibly with lenalidomide or supportive care.I am 18 years old or older.My AML has returned or didn't respond after 1-4 treatments.You are allergic to any of the study medications, including the ingredients in Azacitidine.I do not have any major heart problems.
Research Study Groups:
This trial has the following groups:- Group 1: SL-172154
- Group 2: SL-172154 + Azacitidine
- Group 3: SL-172154 + Azacitidine + Venetoclax
- Group 4: Part D-Previously untreated HR-MDS 1:1:1 Randomization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there copious amounts of medical facilities running this research in Canada?
"This medical research is being conducted at the Baylor Scott & White Research Institute in Dallas, Texas; City of Hope in Duarte, California; Gabrail Cancer Center in Canton, Ohio as well as 9 other clinical centres."
Answered by AI
How many participants are engaging in this research study?
"Affirmative, the details hosted on clinicaltrials.gov specifies that this investigation is actively recruiting participants - a total of 107 individuals from 9 different locations since its posting date of March 17th 2022 and most recent update on November 11th 2022."
Answered by AI
Are there any open slots for volunteer participants in this research endeavor?
"Indeed, current information on clinicaltrials.gov asserts that this experiment is currently seeking volunteers. It was initially posted on March 17th 2022 and last amended November 11th 2022; it requires 107 patients to be recruited across 9 different medical centres."
Answered by AI
Has the Food and Drug Administration provided authorization for SL-172154?
"SL-172154 has only been tested in a Phase 1 trial, thus it has limited clinical evidence backing its safety and efficacy; therefore, our team assigned this medication with a score of one."
Answered by AI
What are the intended outcomes of this medical research?
"The primary aim of this trial, spanning from Day 1 to 90 days after the final dose of SL-172154, is to pinpoint an appropriate Phase 2 dosage for MDS or AML patients receiving either Azacitidine alone or with Venetoclax. Moreover, secondary objectives include measuring disease responses according to IWG 2006 and ELN 2017 criteria respectively; assessing immunogenicity by calculating ADA titer levels; and determining volume distribution rates of SL-172154."
Answered by AI
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