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MDM2-p53 Inhibitor
APG-115 + APG-2575 for Leukemia
Phase 2
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Require laboratory TLS parameters to be within acceptable range and clinical TLS parameters no higher than grade 2 at study baseline, with or without TLS treatment, before initiation of study treatment.
Adequate kidney function, defined as a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing a new cancer drug, APG-115, to see if it is safe and effective at treating T-PLL. The study will enroll 24-36 patients.
Who is the study for?
Adults with T-PLL leukemia who've had at least one prior therapy can join. They must be in good enough health, not have received certain treatments recently, and agree to use contraception. People with severe allergies to the drugs, active infections like HIV or COVID-19, heart problems, other untreated cancers or those needing strong immune system drugs can't participate.Check my eligibility
What is being tested?
The trial is testing APG-115 alone or combined with APG-2575 on patients with T-PLL leukemia. It's an open-label phase IIa study looking at how the body processes these drugs and their safety and effectiveness across multiple centers involving 24-36 participants.See study design
What are the potential side effects?
Potential side effects of APG-115 and APG-2575 may include reactions related to the immune system, liver issues reflected by blood tests changes, fatigue, digestive disturbances such as nausea or diarrhea, skin reactions and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lab tests for tumor lysis syndrome are within safe limits and any symptoms are mild.
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My kidneys work well, with a creatinine clearance rate of at least 50 mL/min.
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My liver enzymes are within acceptable limits.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I have T-PLL that has come back or didn't respond to treatment and I've had at least one prior therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of APG-115
Maximum tolerated dose of APG-115+APG-2575
Trial Design
2Treatment groups
Experimental Treatment
Group I: APG-115 monotherapyExperimental Treatment1 Intervention
APG-115 will be given alone
Group II: APG-115 + APG-2575 combinationExperimental Treatment2 Interventions
APG-115 is given in combination with APG-2575
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APG-115
2016
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,298 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.My lab tests for tumor lysis syndrome are within safe limits and any symptoms are mild.I haven't taken strong medication that affects liver enzymes in the last 14 days or 7 half-lives.I have tested positive for COVID-19.I am not pregnant and agree to use contraception during the study.I do not have active hepatitis B or C, or I am not at risk for hepatitis B reactivation.My kidneys work well, with a creatinine clearance rate of at least 50 mL/min.I need treatment for graft versus host disease or must continue taking drugs that suppress my immune system.My liver enzymes are within acceptable limits.I understand the study's requirements and have signed the consent form.I haven't had chemotherapy or antibody therapy in the last 7 days.I have recovered from previous cancer treatments, except for hair loss or changes in skin color.I am 18 years old or older.I do not have any severe illnesses that could interfere with the study.I can take care of myself and am up and about more than half of my waking hours.I have been treated with an MDM2 inhibitor before.I have no other cancers needing treatment or showing signs of getting worse.I have an active brain tumor that is not under control.I have T-PLL that has come back or didn't respond to treatment and I've had at least one prior therapy.
Research Study Groups:
This trial has the following groups:- Group 1: APG-115 monotherapy
- Group 2: APG-115 + APG-2575 combination
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.
Does the APG-115 drug have governmental approval for use?
"While there is some data suggesting that APG-115 is safe, it only received a 2 because there is no evidence yet that the medication is effective."
Answered by AI
Are new patients still being sought for this experiment?
"The data on clinicaltrials.gov does indicate that this clinical trial is currently recruiting participants. The trial was initially posted on 7/12/2021 and was most recently edited on 7/8/2022. The clinical trial is enrolling 36 patients across 3 locations."
Answered by AI
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