APG-2575 Monotherapy or in Combination With Lenalidomide / Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    May 7, 2024
  • participants needed
    57
  • sponsor
    Ascentage Pharma Group Inc.
Updated on 7 May 2021

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.

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 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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment APG-2575, Rd
Clinical Study IdentifierNCT04674514
SponsorAscentage Pharma Group Inc.
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

monoclonal antibody therapy within 8 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
intolerance to lenalidomide
Plasma cell leukemia, non-secretory multiple myeloma, Fahrenheit macroglobulinemia, 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)
Participant to other clinical trials within 28 days of first dose
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
Prior exposure to any BCL-2-directed therapy for MM
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 inducerstrong CYP2C8 inhibitor (except study treatment)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note