APG-2575 Combinations for Multiple Myeloma

Recruiting at 2 trial locations

Overseen By Angela Kaiser

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ascentage Pharma Group Inc.

Must not be taking: BCL-2 therapy, CYP3A inhibitors

Disqualifiers: Infections, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

108 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, APG-2575, combined with pomalidomide and dexamethasone, for patients with relapsed or non-responsive multiple myeloma. The goal is to find the safest and most effective dose. Pomalidomide, combined with dexamethasone, has been shown to be effective in treating relapsed and refractory multiple myeloma, with a history of use demonstrating its safety and efficacy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you require treatment with a strong cytochrome P450 (CYP) 3A inhibitor or have received antineoplastic therapy within 2 weeks before starting the study treatment.

Research Team

Yifan Zhai, MD, PhD

Principal Investigator

Ascentage Pharma Group Inc.

Eligibility Criteria

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.

Inclusion Criteria

Ability to complete questionnaire(s) by themselves or with assistance (For AL amyloidosis patients only)

I have AL amyloidosis, have had treatment before, and my disease can be measured.

I have MM, treated 1-4 times before, and my condition worsened quickly after the last treatment.

Exclusion Criteria

I have plasma cell leukemia or a similar condition.

I have newly diagnosed multiple myeloma and have had minimal or no treatment.

I have AL amyloidosis and haven't received systemic therapy or have it with multiple myeloma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive APG-2575 in combination with Pd to determine the MTD and RP2D using a 3+3 design

28 days per cycle

Multiple visits per cycle for dose escalation monitoring

Dose Expansion

Participants receive APG-2575 at the determined RP2D to further evaluate safety and efficacy

28 days per cycle

Regular visits per cycle for safety and efficacy assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• APG-2575

Trial Overview 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.

Participant Groups

Group I: APG-2575+LD Experimental Treatment 1 Intervention

APG-2575+ Lenalidomide +Dexa Days 1 through 21 of each 28-day cycle,

Group II: APG-2575 +Pd or LD Experimental Treatment 1 Intervention

APG-2575+ Pomalidomide 4mg QD x 21 days + dexamethasone

APG-2575 is already approved in China, United States for the following indications:

Approved in China as Lisaftoclax for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Approved in United States as Lisaftoclax for:

• None approved yet; under investigation for CLL/SLL, Waldenström macroglobulinemia, multiple myeloma, and acute myeloid leukemia

Who Is Running the Clinical Trial?

Ascentage Pharma Group Inc.

Lead Sponsor

Trials

54

Recruited

5,700+