A Phase Ib/II Open-Label Study of APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma and Immunoglobin Light Chain Amyloidosis

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? APG2575
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG-2575 in combination with Pd/DRd in patients with relapsed/refractory (RR) multiple myeloma (MM). The study consists of dose escalation and dose expansion phases. The study consists of will start with 2 arms noted below, both arms are independent

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years of age

• 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, meanwhile, is defined as disease that progresses on salvage therapy or progresses within 60 days of the last treatment.

• AL amyloidosis patients (for Arm C ONLY): Patients with AL amyloidosis when meeting:

• i. histochemical diagnosis based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens, the type must have been confirmed unequivocally.

• ii. have symptomatic organ involvement. Only purpura and/or carpal tunnel syndrome are not acceptable.

• iii. have at least one prior line of systemic therapy for AL. Patients who do not achieve at least a PR to frontline therapy in 3 months are eligible.

• iv. All MM/AL patients should have measurable disease of AL amyloidosis as defined by at least ONE of the following:

⁃ Serum monoclonal protein ≥1.0 g/dl by protein electrophoresis

⁃ \>200 mg of monoclonal protein in the urine on 24-hour electrophoresis

⁃ Serum differential FLC concentration (dFLC, difference between amyloid forming \[involved\] and nonamyloid forming \[uninvolved\] free light chain \[FLC\]) \> 5 mg/dL; OR serum FLC of 7.5 mg/dL provided the κ/λ FLC ratio is abnormal (κ/λ \<0.26 for patients with monoclonal λ FLC, κ/λ \>1.65 for patients with monoclonal κ FLC).

• Eastern Cooperative Oncology Group (ECOG) ≤ 2

• Life expectancy ≥ 6 months

• Adequate hematologic function defined as:

∙ ANC ≥1.0 x 10\^9/L independent of growth factor support within 7 days of the first dose with study drug

‣ Hemoglobin ≥8 g/dL without transfusion or growth factor support within 7 days of the first dose of study drug

‣ Platelet count ≥ 50 x 10\^9/L without transfusion support within 7 days of the first dose of study drug (for MM patients); or platelet count ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L if bone marrow involvement independent of transfusion support in either (for AL amyloidosis patients).

• Adequate hepatic and renal function defined as:

∙ AST and ALT \< 3 x upper limit of normal (ULN)

‣ Creatinine clearance \>30 mL/min (for MM patients); or Creatinine ≤3 mg/dL and CrCL ≥25 ml/min using the Cockcroft-Gault formula (for AL amyloidosis patients)

‣ Bilirubin\< 1.5 x ULN (Except if considered secondary to Gilbert's syndrome and primarily indirect bilirubinemia)

• PT/INR ≤2 x ULN and PTT (or aPTT) ≤2 x ULN

• Female subjects who are of non-reproductive potential (i.e., post-menopausal by history: no menses for ≥2 year; or history of hysterectomy; or history of bilateral tubal ligation; or history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.

• Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices\[IUDs\], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug

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

Locations
United States
Florida
Mayo Clinic
RECRUITING
Jacksonville
New York
Weil Cornell Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic Hosptials
RECRUITING
Cleveland
Contact Information
Primary
Angela Kaiser
angela.kaiser@ascentage.com
301-509-0357
Time Frame
Start Date: 2021-12-23
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 108
Treatments
Experimental: APG-2575 +Pd or LD
APG-2575+ Pomalidomide 4mg QD x 21 days + dexamethasone
Experimental: APG-2575+LD
APG-2575+ Lenalidomide +Dexa Days 1 through 21 of each 28-day cycle,
Authors
Wensi Li
Sponsors
Leads: Ascentage Pharma Group Inc.

This content was sourced from clinicaltrials.gov

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