APG-2575 Combination Therapy for Waldenström Macroglobulinemia
(MAPLE-1 Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ascentage Pharma Group Inc.

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.

Eligibility Criteria

Adults over 18 with Waldenström Macroglobulinemia who need treatment can join. They must have a life expectancy of at least 3 months, good liver and kidney function, and be generally healthy (ECOG ≤1). Women should use birth control if they can have children. People can't join if they've had certain treatments for WM or other health issues like recent surgery, active infections, heart disease, or bleeding disorders.

Inclusion Criteria

I have Waldenstrom macroglobulinemia needing treatment according to specific guidelines.

My diagnosis of Waldenstrom's macroglobulinemia (WM) is confirmed.

My liver and kidney functions are within the required range.

+6 more

Exclusion Criteria

I haven't had a stroke or brain bleed in the last year.

My condition did not improve after my last treatment with a medicine called rituximab.

I still have side effects from my previous WM treatment.

+16 more

Participant Groups

The trial is testing APG-2575 alone or combined with Ibrutinib or Rituximab to see how safe and effective it is for treating Waldenström Macroglobulinemia. It's also looking at how the body processes the drug. Participants will receive different doses of APG-2575 to find out which one works best.

3Treatment groups

Experimental Treatment

Group I: APG2575 800 mg armExperimental Treatment1 Intervention

APG2575 800 mg arm ramp up

Group II: APG2575 600 mgExperimental Treatment2 Interventions

APG2575 600 mg ramp up arm

Group III: APG2575 400 mgExperimental Treatment3 Interventions

APG2575 400mg ramp up arm

APG2575 is already approved in China for the following indications:

🇨🇳 Approved in China as Lisaftoclax for: