Status:
UNKNOWN
APG-2575 Monotherapy or in Combination With Lenalidomide/DXMS in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Ascentage Pharma Group Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG2575 monotherapy or in combination with lenalidomide (R) and dexamet...
Detailed Description
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG2575 monotherapy or in combination with lenalidomide (R) and dexamet...
Eligibility Criteria
Inclusion
- ≥ 18 years of age;
- Life expectancy ≥ 6 months;
- Eastern Cooperative Oncology Group (ECOG) ≤ 2;
- Corrected QT interval (QTc) based on Frederica or Bazett formula ≤ ≤450ms (male)，or ≤ 470ms (female);
- Patients with Relapsed/Refractory MM, previously treated with at least 1 prior line of therapy for MM;
- Symptomatic MM patients with measurable disease (IMWG 2016);
- Patients with a history of autologous HSCT must have an adequate bone marrow function and have recovered from any transplant-related toxicity, and meet a minimum of 6 months post-autologous transplant (prior to first dose).
- Adequate hematologic function without growth factor support
- Adequate hepatic, renal and coagulation function
- Male and female subjects of childbearing potential who agree to use highly effective methods of birth control during the period of therapy and for 90 days after the last dose of study drug.
- Ability to understand and voluntarily sign a written informed consent form before performing any study procedures.
- Compliance to study procedures.
Exclusion
- monoclonal antibody therapy within 4 weeks prior to first dose; CAR-T therapy within 3 months prior to first dose; or other anti-myeloma therapy within 2 weeks prior to first dose.
- Only Arm B:intolerance to lenalidomide.
- Plasma cell leukemia, non-secretory multiple myeloma, Fahrenheit macroglobulinemia, primary amyloidosis, POEMS syndrome.
- Subjects planning to undergo a stem cell transplant prior to progression of disease on this study, i.e., these subjects should not be enrolled in order to reduce disease burden prior to transplant.
- Subject has previously received an allogenic stem cell transplant (regardless of timing).
- Participated in other clinical trial treatments within 14 days before the first dose (calculated from the time of withdrawal from the study treatment).
- Unable to swallow tablets or malabsorption syndrome, disease significantly affecting gastrointestinal function.
- Known central nervous system involvement.
- Failure to have fully recovered (i.e., ≤ Grade 1 toxicity) from the reversible effects of prior treatment.
- Not recovered from recent surgical procedures based on investigator's discretion. Major surgical procedure within ≤28 days or minor surgical procedure within ≤14 days prior to initiating study treatment, or anticipation of the need for major surgery during the course of the study treatment and 14 days post last treatment, radiotherapy ≤14 days.
- Unstable angina, myocardial infarction, or coronary revascularization within 180 days prior to the first dose.
- Active rheumatoid arthritis, active inflammatory bowel disease, or other chronic inflammatory diseases.
- Active infection need systemic treatment, including HIV antibody positive, HCV Ab or RNA more than ULN, or HBV-DNA more than ULN.
- Severe uncontrollable medical condition, including, but not limited to, symptomatic congestive heart failure, severe arrhythmias, unstable angina, or a psychiatric disorder that may affect study adherence;
- Subject has any concurrent or recent malignancy ≤ 5 year prior to registration with the exception of: basal or squamous cell skin cancer and any carcinoma in situ with adequate therapy, or other cancers successfully cured with surgical procedures or drugs ≥ 2 years.
- Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.
- Female patients who are pregnant or breastfeeding.
- Requires treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor or inducer、strong CYP2C8 inhibitor (except study treatment).
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04674514
Start Date
April 13 2021
End Date
May 1 2024
Last Update
March 7 2023
Active Locations (12)
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1
Beijing Chao-yang Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100020
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
Guangdong Province People's Hospital
Guangzhou, Guangdong, China, 510080
4
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080