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MDM2 Inhibitor

APG-115 + Pembrolizumab for Skin Cancer

Phase 1 & 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
Tumor tissue must be provided for all subjects for biomarker analysis before treatment with investigational product
Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Must not have
Any prior systemic MDM2-p53 inhibitor treatment
Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, APG-115, in combination with pembrolizumab, to see if it is effective in treating cancer.

Who is the study for?
This trial is for adults with metastatic melanomas or advanced solid tumors who have specific heart health measures, can provide tumor tissue samples, and are willing to use effective contraception. It's not for those with active brain metastases, certain recent treatments, uncontrolled illnesses, autoimmune diseases requiring steroids, live vaccines recently taken, or women who are pregnant.
What is being tested?
The study tests APG-115 combined with pembrolizumab. Part 1 finds the safe dose level; Part 2 uses this dose in a larger group to see how well it works against different types of cancer like melanoma and nerve sheath tumors.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs (like lungs), fatigue, skin reactions, hormonal changes affecting normal body functions and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor for testing before starting the trial treatment.
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My heart's pumping ability is within the normal range.
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My side effects from previous cancer treatments are mild.
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My blood tests show my organs and bone marrow are working well.
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My tumor is a type of sarcoma that cannot be removed surgically.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never been treated with MDM2-p53 inhibitors.
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I have a condition like RA or IBD that causes long-term inflammation.
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I have had a transplant of tissue, organ, stem cells, or bone marrow.
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I have had an organ transplant and take medication to suppress my immune system.
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I received lung radiation of more than 30Gy less than 6 months ago.
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I do not have an active infection needing antibiotics or have hepatitis, HIV, or COVID-19.
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I have an autoimmune disease that needs steroids or immunosuppressants.
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I have had pneumonitis treated with steroids or have it now.
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My cancer has a known FGFR gene mutation.
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I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.
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My cancer has spread to my brain or spinal cord.
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I haven't fully recovered from my last surgery as expected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Maximum Tolerated Dose
Overall Response Rate
Recommended Phase II Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: APG-115+pembrolizumab open label, two-part phase Ib/IIExperimental Treatment1 Intervention
single arm dose escalation and dose expansion

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,191 Total Patients Enrolled
Ascentage Pharma Group Inc.Lead Sponsor
51 Previous Clinical Trials
5,387 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma
18 Previous Clinical Trials
1,131 Total Patients Enrolled

Media Library

APG-115 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03611868 — Phase 1 & 2
Melanoma or Solid Tumors Research Study Groups: APG-115+pembrolizumab open label, two-part phase Ib/II
Melanoma or Solid Tumors Clinical Trial 2023: APG-115 Highlights & Side Effects. Trial Name: NCT03611868 — Phase 1 & 2
APG-115 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03611868 — Phase 1 & 2
~3 spots leftby Dec 2024
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