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Anti-tumor antibiotic

APR-1051 for Cancer (ACESOT-1051 Trial)

Phase 1
Recruiting
Research Sponsored by Aprea Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of advanced/metastatic solid tumor
Age ≥ 18 years
Must not have
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy
Major surgery within 21 days prior to Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 28, each cycle is 28 days
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a drug called APR-1051 in patients with advanced solid tumors.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors who are relatively active (ECOG ≤1 or KPS ≥70%). They must have measurable disease, adequate organ function, and agree to use contraception. It's not suitable for those who haven't recovered from previous cancer treatment side effects, except minor neuropathy, hair loss, or skin color changes.
What is being tested?
APR-1051 is being tested in this Phase 1 study to see if it's safe and effective against advanced solid tumors. Participants will take APR-1051 orally. The study will also look at how the body processes the drug and any early signs of its effectiveness.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and dosage levels, specific side effects of APR-1051 are not listed but may include typical reactions seen with other cancer treatments such as fatigue, nausea, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to other parts of my body.
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I am 18 years old or older.
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My cancer can be measured or evaluated by scans.
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I am mostly active and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have another cancer that is spreading or needs treatment.
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I have not had major surgery in the last 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 28, each cycle is 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 28, each cycle is 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended dose of APR-1051
Treatment-related adverse events
Secondary outcome measures
Pharmacokinetics: AUC of APR-1051
Pharmacokinetics: Cmax/Cmin of APR-1051
Pharmacokinetics: Tmax of APR-1051
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: APR-1051Experimental Treatment1 Intervention
Dose Escalation based on BOIN Design

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Who is running the clinical trial?

Aprea TherapeuticsLead Sponsor
13 Previous Clinical Trials
755 Total Patients Enrolled
~53 spots leftby Jun 2027
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