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Small Molecule

APG-2575 Combinations for Multiple Myeloma

Phase 1 & 2
Recruiting
Led By Wensi Li, M. M, MD
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
MM patients (for Arm A and Arm B): Patients with Relapsed/Refractory MM per 2016 IMWG criteria, previously treated with at least 1 but not more than 4 prior lines of therapy for MM. Refractory MM, defined as disease that progresses on salvage therapy or progresses within 60 days of the last treatment.
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug, APG-2575, to see if it is safe and effective in patients with multiple myeloma who have relapsed or are refractory to other treatments. The study will start with two arms, both of which are independent.

Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have had 1-4 prior treatments. They must have good liver and kidney function, a life expectancy of at least 6 months, and be able to perform daily activities with some limitations (ECOG ≤ 2). Women must not be pregnant and all participants should agree to use effective birth control.Check my eligibility
What is being tested?
The study tests APG-2575 in combination with two other drug regimens (DRd or Pd) on patients whose multiple myeloma has returned or didn't respond after treatment. It's an early-phase trial that includes increasing doses to find safe levels before expanding the number of patients.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones may include reactions related to immune system activation, gastrointestinal issues, fatigue, blood-related problems such as anemia or clotting disorders, potential liver or kidney impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have MM, treated 1-4 times before, and my condition worsened quickly after the last treatment.
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I am 18 years old or older.
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I am not able to become pregnant or I have a negative pregnancy test.
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I can perform all my self-care activities and remain up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Dose limiting toxicity

Trial Design

2Treatment groups
Experimental Treatment
Group I: APG-2575+LDExperimental Treatment1 Intervention
APG-2575+ Lenalidomide +Dexa Days 1 through 21 of each 28-day cycle,
Group II: APG-2575 +Pd or LDExperimental Treatment1 Intervention
APG-2575+ Pomalidomide 4mg QD x 21 days + dexamethasone

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,226 Total Patients Enrolled
Wensi Li, M. M, MDPrincipal InvestigatorAscentage Pharma
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,198 Total Patients Enrolled

Media Library

APG-2575 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04942067 — Phase 1 & 2
Amyloidosis Research Study Groups: APG-2575 +Pd or LD, APG-2575+LD
Amyloidosis Clinical Trial 2023: APG-2575 Highlights & Side Effects. Trial Name: NCT04942067 — Phase 1 & 2
APG-2575 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04942067 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a synopsis of previous experiments involving APG2575 + DRd?

"At present, there are 757 active studies for APG2575 + DRd with 169 trials in the Phase 3 stage. While Joliet, Illinois is one of many locations conducting these trials, 26277 sites around the world have been enlisted to participate."

Answered by AI

What is the scope of individuals receiving treatment in this trial?

"To reach the target of 108 qualified participants, Ascentage Pharma Group Inc., will be running this trial at multiple sites such as Mayo Clinic in Jacksonville and Cleveland Clinic Hosptials in Ohio."

Answered by AI

Is this study currently open to new participants?

"Affirmative. According to clinicaltrials.gov, this trial is actively seeking suitable candidates and was first published on December 23rd 2021. The most recent edit was made on February 28th 2022, with 108 volunteers needed from 3 different locations."

Answered by AI

Is it possible for me to participate in this clinical trial?

"Applicants to this trial need to have a diagnosis of amyloidosis and be between 18 and 99 years old. The capacity for the study is 108 participants."

Answered by AI

Does this clinical trial allow adults over the age of thirty to participate?

"This medical trial requires applicants to be between 18 and 99 years of age. It should also be noted that there are 124 clinical trials designed for those under the legal threshold, as well as 1560 studies catered towards elderly individuals."

Answered by AI

What clinical conditions does the combination of APG2575 and DRd typically address?

"APG2575 + DRd is frequently prescribed for ophthalmia, sympathetic and can be used to treat a range of issues such as at least two previous systemic chemotherapy regimens, branch retinal vein occlusion, macular edema."

Answered by AI
~13 spots leftby Sep 2024