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.
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. This study consists of two arms of APG-2575 single agent (arm A) and APG-2575 in combination with Rd (arm B). All subjects will receive consecutive treatment in 28-day cycles. All subjects will continue to receive treatment until disease progression, unacceptable toxicities, or other treatment discontinuation criteria fdefined by the protocol. All subjects will complete survival follow up after treatment discontinuation until end of the study, withdrawal of informed consent, loss of follow-up, or death.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
APG-2575 orally once daily, every 28 days as a cycle.
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.
Beijing Chao-yang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangdong Province People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShenzhen Second People's Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGUnion Hospital Tongji Medical College of Huazhong University of Science ang Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
NOT_YET_RECRUITINGPeople's hospital of Jiangsu Province
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITING...and 2 more locations
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.
Time frame: 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.