Multiple MyelomaPhase 1/2NCT04674514
APG-2575 Monotherapy or in Combination With Lenalidomide/DXMS in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing APG-2575 and Rd in people with Multiple Myeloma, run by Ascentage Pharma Group Inc. at 12 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- APG-2575 and Rd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 12 sitesChina
- Study dates
- 13 Apr 2021to May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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);
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Beijing Chao-yang Hospital of Capital Medical University
Beijing, Beijing Municipality, 100020
Zhongxia Huang, Ph.D
Zhongxia Huang, Ph.D
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhongjun Xia, Ph.D
Zhongjun Xia, Ph.D
- Not yet recruiting
Guangdong Province People's Hospital
Guangzhou, Guangdong, 510080
Jianyu Weng, Ph.D
Jianyu Weng, Ph.D
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Juan Li, Ph.D
Juan Li, Ph.D
- Not yet recruiting
The First Affilated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhen Cai, Ph.D
Zhen Cai, Ph.D
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Wenbin Qian, Ph.D
Wenbin Qian, Ph.D
- Not yet recruiting
People's hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
Lijuan Chen, Ph.D
Lijuan Chen, Ph.D
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518025
Xin Du, Ph.D
Xin Du, Ph.D
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengzheng Fu, MD., +86-0512-67781856, fuzhengzheng@suda.edu.cn
- Not yet recruiting
Union Hospital Tongji Medical College of Huazhong University of Science ang Technology
Wuhan, Hubei, 215316
Mei Hong, Ph.D
Mei Hong, Ph.D
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
Fuling Zhou, Ph.D
Fuling Zhou, Ph.D
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Baijun Fang, Ph.D
Baijun Fang, Ph.D
About this study
Official title: Phase Ib / II Open-Label Stduy of APG-2575 Monotherapy or in Combination With Lenalidomide / Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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.
Read the 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 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.
- Conditions
- Multiple Myeloma
- Being tested
- APG-2575, Rd
- Keywords
- Multiple myeloma, Bcl-2 inhibitor, APG-2575
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-2575Drug
APG-2575 orally once daily, every 28 days as a cycle.
RdDrug
Also called Lenalidomide +Dexamethasone
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Single agent) | Experimental | Dose escalation APG-2575 at 3 dose levels 3+3 design. Receives: Drug: APG-2575 |
| Arm B (combo) | Experimental | Dose escalation APG-2575 at 3 dose levels in combination with Rd, 3+3 design. Receives: Drug: APG-2575; Drug: Rd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start13 Apr 2021
- Primary completionJan 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yifan Zhai, MD, PhD, Study chair, Suzhou Yasheng Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674514
- Sponsor's protocol ID
- APG2575MC101
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib / II Open-Label Stduy of APG-2575 Monotherapy or in Combination With Lenalidomide / Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04674514
- Acronym / sponsor ID
- APG2575MC101
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Bcl-2 inhibitor, APG-2575
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Single agent) | Experimental | Drug: APG-2575Dose escalation APG-2575 at 3 dose levels 3+3 design. |
| Arm B (combo) | Experimental | Drug: APG-2575, Drug: RdDose escalation APG-2575 at 3 dose levels in combination with Rd, 3+3 design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 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;
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-2575APG-2575 orally once daily, every 28 days as a cycle. | Drug | Arm A (Single agent), Arm B (combo) |
| RdAlso: Lenalidomide +DexamethasoneLenalidomide 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. | Drug | Arm B (combo) |
Primary outcome
Dose Limiting Toxicity
Time frame: 28 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yifan Zhai, MD, PhD study chair
Suzhou Yasheng Pharmaceutical Co., Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APG-2575 and Rd in people with Multiple Myeloma, run by Ascentage Pharma Group Inc. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianping Ning (+86-010-67091790, jianping.ning@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.