APG-2575 Monotherapy or in Combination With Lenalidomide/DXMS in Subjects With Relapsed or Refractory Multiple Myeloma
Phase Ib / II Open-Label Stduy of APG-2575 Monotherapy or in Combination With Lenalidomide / Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
1 other identifier
interventional
48
1 country
12
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 dexamethasone (d) in patients with relapsed/refractory (R/R) multiple myeloma (MM). The primary objective is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD) and the recommended dose (RP2D) of APG-2575 monotherapy or in combination with Rd in Chinese R/R MM patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Apr 2021
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMarch 7, 2023
March 1, 2023
2.7 years
December 15, 2020
March 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 28 days of study treatment. These will be assessed via CTCAE version 5.0.
28 days
Study Arms (2)
Arm A (Single agent)
EXPERIMENTALDose escalation APG-2575 at 3 dose levels 3+3 design.
Arm B (combo)
EXPERIMENTALDose escalation APG-2575 at 3 dose levels in combination with Rd, 3+3 design.
Interventions
Lenalidomide administered at a dose of 25 mg orally (PO) on Days 1 through 21 of each 28-day cycle, dexamethasone administered at a dose of 40 mg (or 20 mg for patients\>75 years old) on Days 1, 8, 15, and 22 of a repeated 28-day cycle.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Chao-yang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100020, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518025, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Union Hospital Tongji Medical College of Huazhong University of Science ang Technology
Wuhan, Hubei, 215316, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062, China
People's hospital of Jiangsu Province
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affilated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yifan Zhai, MD, PhD
Suzhou Yasheng Pharmaceutical Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 19, 2020
Study Start
April 13, 2021
Primary Completion
January 1, 2024
Study Completion
May 1, 2024
Last Updated
March 7, 2023
Record last verified: 2023-03